BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS HAND CONTROLLED CURVED SHEA

    MDR report key: 1170362 · Received September 12, 2008

    Report

    Report Number
    3005075853-2008-01673
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 21, 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
    CO, US
    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 LAP ADJUSTABLE BAND PROCEDURE, FIVE MINUTES INTO THE CASE, THE WHITE TISSUE PAD CURLED AT THE DISTAL END OF THE JAWS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 E4L984

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE