Events

Recall of Device Recall OmniGuide BPROBOTIC

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

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
    63642
  • Event Risk Class
    Class 2
  • Event Number
    Z-0453-2013
  • Event Initiated Date
    2012-11-05
  • Event Date Posted
    2012-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114404
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Reason
    Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient.
  • Action
    OmniGuide issued letter notifiction on November 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that an OmniGuide sales representative would contact them immediately to recover the affected product. For any questions customers were instructed to call 617-551-8561. For questions regarding this recall call 617-551-8410.

Device

Device Recall OmniGuide BPROBOTIC
  • Model / Serial
    Lot Numbers: LA121003AO-P1 LA121003AQ-P1 LA121001CB-P1 LA121003AL-P1 LA121002AC-P1 LA121001CC-P1 LA121001BZ-P1 LA121001BZ-P1 LA121001AR-P1 LA121001AQ-P1 LA121001CA-P1 LA120926BA-P1 LA120926AS-P1 LA120919BG-P1 LA120920AF-P1 LA120924AG-P1        :
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, FL, MA, NY, OH, and OR.
  • Product Description
    OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use || Cat. # BP-ROBOTIC || The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy
  • Manufacturer
    OmniGuide, Inc.

Manufacturer

OmniGuide, Inc.
  • Manufacturer Address
    OmniGuide, Inc., One Kendall Square, Building 100, 3rd floor, Cambridge MA 02139-1562
  • Manufacturer Parent Company (2017)
    OmniGuide Inc.
  • Source
    USFDA