BEUDAMED
    FDA Adverse Event Other Summary report: N

    TISCHLER BIOPSY FORCEPS, 9", POINTED JAWS, 3MMX8M

    MDR report key: 2200669 · Received March 7, 2008

    Report

    Report Number
    8010877-2008-00001
    Event Type
    Other
    Date Received
    March 7, 2008
    Report Date
    February 29, 2008
    Manufacturer
    KOSCHER & WUERTZ GMBH
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE INSTRUMENT IS IN ACCORDANCE WITH THE SPECIFICATIONS. WE ARE UNABLE TO SAY WHAT EXACTLY THE ROOT CAUSE OF THE BREAKAGE WAS. DUE TO THE FACT THAT BOTH HINGE PINS HAVE SHORN OFF AND BASED ON THE INFO ON HAND, OUR ASSUMPTION IS THAT THE BREAKAGE WAS CAUSED BY AN OVERSTRESSING. INTEGRA LIFESCIENCES CORPORATION IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR (B)(4). THE MANUFACTURER HAS BEEN NOTIFIED OF THE REPORTED COMPLAINT. ADDITIONAL INFO FROM THE IMPORTER REPORT: (B)(6) 2008. MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE POINTED MOVEABLE JAW OF THE INSTRUMENT BROKE OFF IN THE POSTERIOR FORNIX (VAGINA). THE JAW WHICH WAS BROKEN OFF WAS NOT RETURNED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISCHLER BIOPSY FORCEPS, 9", POINTED JAWS, 3MMX8M FORCEPS KNW KOSCHER & WUERTZ GMBH 0040548

    Patients

    Seq Age Sex Outcome Treatment
    1