BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-HOOK ELECTRO SURGICAL

    MDR report key: 5630045 · Received April 30, 2016

    Report

    Report Number
    MW5062069
    Event Type
    Malfunction
    Date Received
    April 30, 2016
    Date of Event
    April 20, 2016
    Report Date
    April 30, 2016
    Manufacturer
    DAVOL INC. SUB. C R BARD INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SINGLE USE L-HOOK ELECTROSURG LAPAROSCOPIC ATTACHMENT (DAVOL, (B)(4)ELECTRICAL SPARKS FROM SHEET, SOME 2-3 CM AWAY FROM HOOK TIP (WHERE ELECTROSURGERY IS INTENDED TO OCCUR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277805 L-HOOK ELECTRO SURGICAL L-HOOK ELECTRO SURGICAL GEI DAVOL INC. SUB. C R BARD INC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other