BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT

    MDR report key: 1813077 · Received August 19, 2010

    Report

    Report Number
    3005075853-2010-04744
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 23, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER DECIDED NOT TO RELEASE DEVICE FOR ANALYSIS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFORMATION, THE MANUFACTURING RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MANUFACTURING OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT HEMI COLECTOMY PROCEDURE, ON THE THIRD FIRING, THE DEVICE CUT AND PARTIALLY STAPLED. DUE TO THE MALFUNCTION OF THE DEVICE, FIVE ADDITIONAL INCHES OF BOWEL HAD TO BE RESECTED. THIS DID NOT HAVE A NEGATIVE IMPACT ON THE PT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA G4T66G

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE