BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 33MM

    MDR report key: 1250743 · Received December 2, 2008

    Report

    Report Number
    3005075853-2008-03356
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Report Date
    November 24, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    OCW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 12/01/2008. INFORMATION IS UNAVAILABLE, DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON RESECTION PROCEDURE, THE DEVICE WAS DIALED DOWN AND THEY DID NOT HEAR THE CRUNCH, AND THERE WERE STAPLES MISSING. THEY REMOVED THE DEVICE AND SAW THAT THERE WERE STAPLES MISSING AND, THEN TRIED TO FIRE IT AGAIN, AND THERE WERE STAPLES MISSING FROM THIS FIRING AS WELL. THEY OPENED ANOTHER DEVICE AND WERE ABLE TO COMPLETE WITH NO PATIENT CONSEQUENCES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 33MM OCW ETHICON ENDO-SURGERY, LLC. NA D4HR2P

    Patients

    Seq Age Sex Outcome Treatment
    1