Events

Recall of Device Recall Broncho Flexible Fiberscope

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Karl Storz Endoscopy America 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
    66862
  • Event Risk Class
    Class 2
  • Event Number
    Z-0527-2014
  • Event Initiated Date
    2013-11-13
  • Event Date Posted
    2013-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123807
  • 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
    Nasopharyngoscope (flexible or rigid) - Product Code ECQ
  • Reason
    Karl storz endoscopy america, inc. is recalling the flexible broncho fiberscope or a flexible intubation fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (tpu), which is not listed in sterrad systems claims for interior endoscope lumens.
  • Action
    The firm, KARL STORZ, sent a "A SAFETY ALERT-ATTENTION NEEDED" letter dated November 8, 2013 to all their customers on November 13, 2013. The letter describes the product, problem and actions to be taken.The letter informs the customers that the endoscopes incorporated a lumen material that is only approved for use as an external surface material and not included in the STERRAD NX and 100NX FDA-cleared claims for use in flexible endoscope lumens. The customers were instructed to follow the recommended processing methods included in the letter. Customers with questions about the letter are instructed to contact the undersigned and the Technical Services at (800) 421-0837, ext 5350.

Device

Device Recall Broncho Flexible Fiberscope
  • Model / Serial
    C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. || " Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias " Uncontrolled hypertension " Bleeding disorder or use of anticoagulants.
  • Manufacturer
    Karl Storz Endoscopy America Inc

Manufacturer

Karl Storz Endoscopy America Inc
  • Manufacturer Address
    Karl Storz Endoscopy America Inc, 15 Wells St, Southbridge MA 01550-4503
  • Manufacturer Parent Company (2017)
    Karl Storz SE & Co. KG
  • Source
    USFDA