BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS HAND CONTROLLED CURVED SHEA

    MDR report key: 1160681 · Received September 5, 2008

    Report

    Report Number
    3005075853-2008-01546
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 09/05/2008: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A ROUX EN Y GASTRIC BYPASS. THE DEVICE ACTIVATION BUTTONS FAILED TO WORK. DEVICE WOULD NOT PASS PRE-TESTING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS HAND CONTROLLED CURVED SHEA GEI ETHICON ENDO-SURGERY, LLC NA E4L63V

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR