BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2925738 · Received January 22, 2013

    Report

    Report Number
    3005075853-2013-00298
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    November 2, 2012
    Report Date
    January 10, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHOTOGRAPH ANALYSIS PHOTOGRAPHS WERE RECEIVED DEMONSTRATING PROBLEM OBSERVED IN THE CASE. ALL PHOTOGRAPHS APPEAR TO BE FROM A DRY FIRING CONDUCTED ON THE BACK TABLE DURING THE PROCEDURE, THERE IS NO INDICATION OF THE STAPLE HEIGHT SELECTION THAT WAS USED. PHOTOGRAPH 1: SHOWS TWO SLIGHTLY MALFORMED STAPLES. THE MALFORMATIONS CONSIST OF A 3 DIMENSIONAL/PLANE 'B' SHAPE THAT HAS ONE OF THE LOOPS LARGER THAN THE OTHER AND WITH STAPLE LEGS OF DIFFERENT LENGTH AND NON SYMMETRICAL POSITIONING. PHOTOGRAPH 2: THIS SHOT IS LOOKING DOWN AT THE SURFACE OF THE ANVIL'S DISTAL HALF. THE VIEWING IS AT A SLIGHT ANGLE LOOKING INTO THE STAPLE FORMING POCKETS. THERE WERE VARYING DEGREES OF STAPLE FORMS RANGING FROM GOOD TO EXTREMELY DEFORMED. THE MOST SEVERE DEFORMATION APPEARS TO BE ALONG THE OUTER TOP ROW AS VIEWED ON THE PHOTOGRAPH. SOME STAPLES IN THAT ROW HAVE STAPLES WITH A SINGLE LEG STICKING OUT AND LEANING LEFT TO RIGHT AND A VERY SMALL COMPRESSED ASSOCIATED LOOP. BASED ON THE PHOTOGRAPHIC EVIDENCE THE STAPLE FORMS DISPLAYED ARE THE RESULT OF CARTRIDGE CHANNEL AND ANVIL HALVES MISALIGNMENT. THIS IS A POTENTIAL CAUSED. WITHOUT A DEVICE, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS THAT DURING A COLON PROCEDURE, THERE WERE MALFORMED STAPLES. AT THE FIRST USE THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29171 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CC0R

    Patients

    Seq Age Sex Outcome Treatment
    1