BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAWAHLE TENACULUM FORCEPS

    MDR report key: 4213609 · Received September 23, 2014

    Report

    Report Number
    9610617-2014-00048
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 5, 2014
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GCJ
    PMA / PMN Number
    K935071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVAL. THE FORCEPS HAS A MFG DATE OF (B)(4) 2003. THEY WERE PURCHASED IN (B)(4) 2005 AND HAS BEEN IN USE FOR APPROX 9 YEARS.

    Description of Event or Problem · 1

    ALLEGEDLY, THE DOCTOR WAS PERFORMED A HYSTEROSCOPY WHEN ONE OF THE JAWS ON THE FORCEPS BROKE OFF IN THE PT. THE DOCTOR HAD TO CONVERT TO OPEN PROCEDURE TO LOCATE AND RETRIEVE THE BROKEN PIECE. PROCEDURE WAS COMPLETED; THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591041 SAWAHLE TENACULUM FORCEPS FORCEPS GCJ KARL STORZ GMBH & CO. KG 33310UM FE

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention