BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPROCESSED BIOPSY FORCEPS

    MDR report key: 1588897 · Received January 15, 2010

    Report

    Report Number
    2134070-2010-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 2, 2009
    Report Date
    January 15, 2010
    Manufacturer
    STERILMED, INC.
    Product Code
    NLU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A THOROUGH INVESTIGATION OF THE DEVICE IN QUESTION WAS CONDUCTED AND THE ROOT CAUSE OF THE ALLEGED FAILURE COULD NOT BE IDENTIFIED. THE DEVICE WAS VISUALLY INSPECTED, AND ALSO WAS TESTED FOR FUNCTIONALITY, USING THE STANDARD BIOPSY FORCEPS PERFORMANCE TEST METHODS AND THE DEVICE MET ALL OF THE ACCEPTANCE CRITERIA. THERE WAS NO PT INJURY REPORTED WITH THE EVENT, BUT STERILMED WILL CONTINUE TO MONITOR THIS CASE AND WILL MAKE FDA AWARE OF ANY ADVERSE HEALTH EVENTS ASSOCIATED WITH THIS SITUATION SHOULD ANY ARISE. STERILMED'S METHOD OF REPROCESSING BIOPSY FORCEPS INVOLVES THOROUGH INSPECTION FOR ANY IRREGULARITY THAT MAY HAVE THE POTENTIAL TO COMPROMISE DEVICE PERFORMANCE PRIOR TO SHIPMENT TO THE CUSTOMER. THE NATURE OF THIS EVENT HAS BEEN REPORTED IN THE MAUDE DATABASE BY OTHER MFRS BEFORE, AND IS OFTEN ATTRIBUTED TO IMPROPER USE OF THE DEVICE BY THE HEALTH CARE PRACTITIONER.

    Description of Event or Problem · 1

    A REPROCESSED BIOPSY FORCEPS WAS REPORTED TO TEAR THE PT'S COLON DURING A PROCEDURE. THERE WAS NO REPORTED ADVERSE IMPACT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPROCESSED BIOPSY FORCEPS BIOPSY FORCEPS NLU STERILMED, INC. 1333

    Patients

    Seq Age Sex Outcome Treatment
    1