BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS HAND CONTROLLED CURVED SHEAR

    MDR report key: 1152686 · Received September 10, 2008

    Report

    Report Number
    1527736-2008-03682
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    April 16, 2008
    Report Date
    May 28, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 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 AN UNKNOWN PROCEDURE, THE DEVICE DID NOT WORK AT ALL AFTER SET UP. THERE WAS NO ERROR CODE REPORTED. THEY OPENED A NEW PRODUCT AND IT WORKED FINE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS HAND CONTROLLED CURVED SHEAR GEI LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA E4K836

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE