Events

Recall of Device Recall LigaSure V 5 mm Dolphin Tip Laparoscopic

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Covidien, PLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60462
  • Event Risk Class
    Class 2
  • Event Number
    Z-0640-2012
  • Event Initiated Date
    2011-11-04
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105466
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching.
  • Action
    Covidien sent an Urgent Medical Device Recall letter dated November 9, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory, Complete the attached Recalled Product Return Form in its entirety. Fax the completed form to (203) 822-6009 and include a copy of the completed form with the products being returned. If customers did not have any units from the affected lots in their inventory, simply return the recall form, via fax or email to: SDFeedback@Covidien.com, indicating you have zero (0) units. If the affected product was purchased directly from Covidien, return product as follows: Customers should contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722-8772, option 1, to obtain a Return Goods Authorization (RGA) prior to returning the affected units. Covidien will arrange for shipment pickup and will cover all freight costs associated with the return. Ship affected products with the RGA # provided by Customer Service to: Covidien, Surgical Solutions Building 4/Receiving 5920 Longbow Drive Boulder, CO 80301 If the affected product was purchased from a distributor, customers should contact their distributor to obtain instructions for return of their affected product. Customers will receive a credit for all products returned. For questions call 303-530-6227

Device

Device Recall LigaSure V 5 mm Dolphin Tip Laparoscopic
  • Model / Serial
    Lot numbers: S1CB001, S1CB002, S1CB003, S1CB004, S1CB005, S1CB006, S1CB007R, S1CB008X, S1CB009X, S1CB012RX, S1CB013PRX, S1CB014PRX, S1CB015PRX, S1CB016PRX, S1CB017PRX, S1CB018PRX, S1CB019PRX, S1CB020PRX, S1CB021PRX, S1CB022PRX, S1CB023PRX, S1CB024PRX, S1CB025PRX, S1DB006X, S1DB007X, S1DB008X, S1DB009X, S1DB010X, S1DB011X, S1DB012X, S1DB013X, S1DB014X, S1DB015X, S1DB016X, S1DB017X, S1DB018X, S1DB019X, S1DB020X, S1DB021X, S1DB022X, S1DB023X, S1EB001X, S1EB002X, S1EB003X, S1EB004X, S1EB005X, S1EB006X, S1EB007RX, S1EB008RX, S1EB009X, S1EB010RX, S1EB011RX, S1EB016P, S1EB017P, S1EB018P, S1EB019P, S1EB020P, S1EB021P, S1EB022P, S1EB023P, S1EB024P, S1EB025P, S1EB026P, S1EB027P, S1EB028P, S1EB029P, S1EB030P, S1EB031P, S1EB032P, S1EB033P, S1EB034P, S1EB035P, S1EB036P, S1EB037P, S1EB038P, S1EB039P, S1EB040P, S1EB041P, S1EB042P, S1FB001P, S1FB005PX, S1FB006PX, S1FB007PX, S1FB008PX, S1FB009PX, S1FB010PX, S1FB011PX, S1FB012PX, S1FB013PX, S1FB014PX, S1FB015PX, S1FB016PX, S1FB017PX, S1FB027PX, S1FB028PX, S1FB029PX, S1FB040X, S1FB041X, S1fb042X, S1FB043X, S1FB044X, S1FB045X, S1FB046X, S1FB047X, S1FB048X, S1FB052X, S1GB001X, S1GB002X, S1GB003x, S1GB004X, S1GB009X, S1GB010X, S1GB011X, S1GB012X, S1GB013X, S1GB014X, S1GB015X, S1GB016X, S1GB017X, S1GB018X, S1HB002, S1HB003, S1HN004, S1HB005, S1HB006, S1HB007, S1HB008, S1HB009P, S1HB014P, S1HB015P, S1HB016P, S1HB017P, S1HB018P, S1HB019, S1HB021X, S1HB022X, S1HB023X, S1HB024X, S1HB027PX, S1HB028PX, S1HB029PX, S1HB031X, S1HB032X, S1HB033X, S1JB034X, S1JB035X, S1JB036X, S1JB038PX, S1JB041X, S1JB042X, S1JB043X, S1JB044PX, S1JB045PX, S1JB046X, S1JB047X, S1JB048X.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatamala, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Netherlands, Norway, Oman, Panama, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Tunisia, Turkey, UAE, UK, and Vietnam.
  • Product Description
    LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for Valleylab, a division of Tyco Healthcare Group LP, Boulder, CO. Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Road, Shanghai 201114, P.R. Chin., || Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.
  • Manufacturer
    Covidien, PLC

Manufacturer

Covidien, PLC
  • Manufacturer Address
    Covidien, PLC, 5920 Longbow Dr, Boulder CO 80301-3202
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA