BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS HAND CONTROLLED CURVED SHEAR

    MDR report key: 1182770 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03711
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    February 18, 2008
    Report Date
    May 5, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/13/2008. EVAL SUMMARY: THE DEVICE WAS RECEIVED IN GOOD CONDITION. NO VISIBLE DAMAGE WAS NOTED. THE HAND-ACTIVATION CONTACTS WERE IN GOOD CONDITION. THE DEVICE WAS TESTED ON A GENERATOR AND IT WAS FOUND THAT THE HAND CONTROL SWITCH ASSEMBLY BUTTONS WERE NOT FUNCTIONAL. HOWEVER, IT WORKED PROPERLY WITH FOOT SWITCH ASSEMBLY. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP NEPHRECTOMY PROCEDURE, THE DEVICE DID NOT WORK. IT WOULD NOT GO THROUGH THE TEST CYCLE. UNK HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS HAND CONTROLLED CURVED SHEAR NONE GEI ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4JM9T

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR