BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2863657 · Received December 10, 2012

    Report

    Report Number
    3005075853-2012-05527
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 20, 2012
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE ANVIL MISSING, OTHERWISE IN GOOD VISUAL CONDITION. AS THE ORIGINAL ANVIL WAS NOT RECEIVED, FURTHER INVESTIGATION WITH THE ORIGINAL ANVIL COULD NOT BE PERFORMED. THE BREAKAWAY WASHER WAS NOT PRESENT AND THERE WERE NO STAPLES PRESENT. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY WITH A TEST ANVIL; IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT WHEN REMOVING THE DEVICE; OPEN THE INSTRUMENT BY TURNING THE ADJUSTING KNOB COUNTERCLOCKWISE. FOR EASY REMOVAL, ONLY OPEN THE INSTRUMENT ONE-HALF TO THREE-FOURTHS REVOLUTIONS. TO ASSURE THE ANVIL IS FREE FROM TISSUE, ROTATE THE INSTRUMENT 90° IN BOTH DIRECTIONS. TO WITHDRAW THE OPEN INSTRUMENT, GENTLY APPLY REARWARD TRACTION WHILE SIMULTANEOUSLY ROTATING. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN LOW ANTERIOR RESECTION, THE DEVICE COULD NOT BE REMOVED AFTER THE DEVICE WAS FIRED. WHEN THE ADJUSTING KNOB WAS LOOSENED A LOT, THE ANVIL SIDE WHICH HAD NOT BEEN ANASTOMOSED CAME OFF. THE STAPLES WERE UNFORMED. ANOTHER DEVICE AND THE FORMER ANVIL WERE USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE THICKNESS OF THE TARGET TISSUE WAS REGULAR. THE TARGET TISSUE WAS CLAMPED UNIFORMLY. THE DEVICE WAS NOT FIRED ON SOMETHING HARD SUCH AS A STAPLE LINE. THE PURSE-STRING INSTRUMENT WAS USED FOR THE ANVIL SIDE PURSE-STRING SUTURE. THE ANVIL WAS SET UNTIL A CLICKING NOISE WAS HEARD. THE INDICATOR WAS IN THE GREEN ZONE WITHIN THE GAP SETTING SCALE. THERE WAS NO UNEXPECTED RESISTANCE AT THE FIRING. THE HANDLE WAS GRASPED FULLY AT THE FIRING. THE SOUND WHICH WAS HEARD WHEN THE WASHER WAS PUNCHED OUT WAS HEARD. THE UNFORMED STAPLES WERE DEPLOYED ALL OVER THE TARGET TISSUE. AS THE TARGET TISSUE WAS NOT RESECTED AT ALL AT THE FIRING, NO DOUGHNUTS WERE CONFIRMED. REINFORCEMENT MATERIAL WAS NOT USED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1