BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC CAUTERY HOOK

    MDR report key: 185285 · Received August 31, 1998

    Report

    Report Number
    185285
    Event Type
    Malfunction
    Date Received
    August 31, 1998
    Date of Event
    August 11, 1998
    Report Date
    August 21, 1998
    Manufacturer
    ELMED INC
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A LAPAROSCOPIC CAUTERY HOOK TIP BROKE HALF WAY THROUGH CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSCOPIC CAUTERY HOOK 30CM INSULATED L-HOOK KNS ELMED INC 52205-678 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR