BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS ACE 14 CM SCISSOR HANDLE

    MDR report key: 1203791 · Received October 10, 2008

    Report

    Report Number
    3005075853-2008-02292
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Report Date
    September 18, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/10/2008. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL. THE HAND ACTIVATION ASSEMBLY BUTTONS WORKED AS INTENDED. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE BUTTONS WERE STICKING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS ACE 14 CM SCISSOR HANDLE LFL ETHICON ENDO-SURGERY, LLC. NA D4HV22

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE