BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 3033706 · Received April 3, 2013

    Report

    Report Number
    3005075853-2013-01575
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ADJUSTING KNOB. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN THE OPEN POSITION AND WITH STAPLES PRESENT. THE BREAKAWAY WASHER WAS PRESENT AND UNCUT. NO FUNCTIONAL TEST COULD BE PERFORMED, AS THE ROTATING KNOB WAS NOTED TO BE DAMAGED NOT ALLOWING THE DEVICE TO OPEN OR CLOSE. IN ADDITION THE FIRING TRIGGER SHROUD WAS DAMAGED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE KNOB-ROTATING PIN WAS NOTED TO BE BROKEN NOT ALLOWING THE DEVICE TO WORK AS INTENDED. THE DAMAGE TO THE ROTATING KNOB MAY HAVE BEEN DUE TO AN EXCESS FORCE APPLIED WHILE TRYING TO CLOSE OR OPEN THE DEVICE. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE WHEN THE PRODUCT MALFUNCTIONED AND DID NOT PIERCE THE RECTAL STUMP, WHERE THE ROTATING KNOB WAS WINDING WITHOUT PIERCING THE TISSUE. THE DEVICE DID NOT OPEN DURING SURGERY. NO CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136521 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CU5C

    Patients

    Seq Age Sex Outcome Treatment
    1