BEUDAMED
    FDA Adverse Event Other Summary report: N

    L-HOOK IRRIGATING CAUTERY INSTRUMENT

    MDR report key: 67364 · Received February 7, 1997

    Report

    Report Number
    MW1010690
    Event Type
    Other
    Date Received
    February 7, 1997
    Date of Event
    February 5, 1997
    Report Date
    February 5, 1997
    Manufacturer
    KARL STORZ ENDOSCOPY
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOOK TIP DETACHED FROM INSTRUMENT DURING SURGICAL PROCEDURE. IT WAS DETERMINED BY X-RAY EXAMINATION THAT THE PORTION MISSING FROM THE INSTRUMENT WAS REMAINING IN THE PT. IRRETREVABLE BY THE SURGEON. DR ATTEMPTED RETRIEVAL BUT DUE TO THE LOCATION, SIZE AND COMPOSITION OF THIS METAL PART, HE CHOSE NOT TO REMOVE IT. SIZE IS THE SAME AS A SLIP USED DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-HOOK IRRIGATING CAUTERY INSTRUMENT IRRIGATING CAUTERY INSTRUMENT KNS KARL STORZ ENDOSCOPY 28775 UF *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other LAPAROSCOPY INSTRUEMTNS, VIDEO, ECT