BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS ACE 14 CM SCISSOR HANDLE

    MDR report key: 1172491 · Received September 22, 2008

    Report

    Report Number
    3005075853-2008-01856
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Report Date
    August 29, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HERNIA PROCEDURE, THE HAND ACTIVATING KNOB DID NOT FUNCTION. NO FURTHER INFORMATION IS AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS ACE 14 CM SCISSOR HANDLE LFL ETHICON ENDO-SURGERY, LLC NA D4J72Y

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR