BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON ENDOSURGERY LLC

    MDR report key: 826795 · Received March 7, 2007

    Report

    Report Number
    MW1042171
    Event Type
    Other
    Date Received
    March 7, 2007
    Date of Event
    January 31, 2007
    Manufacturer
    ETHICON ENDO SURGERY INC
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY THE CLIP APPLIERS (ETHICON ER 320) INTERMITTENTLY WOULD NOT CLOSE AROUND VESSEL. THIS WAS A NEW CLIP APPLIER. WE THEN OPENED A REPROCESSED CLIP APPLIER (ETHICON ER320) AND THAT WAS STICKING AT THE TIP AND NOT OPENING NORMALLY. MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOSURGERY LLC LIGACLIP ERCA 20 MED/LG GDO ETHICON ENDO SURGERY INC REF ER 320 D4G534

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other