BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2050961 · Received April 12, 2011

    Report

    Report Number
    3005075853-2011-01465
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND THE FOLLOWING RESPONSE RECEIVED ON (B)(6) 2011: PATIENT HAS BEEN DISCHARGED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND THE FOLLOWING RESPONSE RECEIVED ON (B)(4) 2011: (B)(6) COULD NOT COMPLETE THE CASE LAPAROSCOPICALLY AND HAD TO CONVERT TO OPEN. HE MADE AN INITIAL MINI-LAPAROTOMY TO RESECT THE SIGMOID AND TO DROP THE ANVIL DOWN IN THE PELVIS. AFTER TESTING THE CIRCULAR STAPLE LINE, HE NOTICED AIR BUBBLES AND A HOLE ON THE POSTERIOR SIDE OF THE ANASTOMOSIS. AT THIS POINT, HIS MINI-LAPAROTOMY WAS EXTENDED TO AN OPEN INCISION. HE HAD TO HAND SEW AND OVER SEW WHERE THE LEAK WAS SPOTTED. TO MY KNOWLEDGE, THE PATIENT'S STAY WAS NOT EXTENDED AS A RESULT OF THE INCIDENT. I BELIEVE THE PATIENT HAS BEEN RELEASED. THE PRE-OP DIAGNOSIS WAS RECURRENT DIVERTICULITIS, SO NO RADIATION OR CHEMO TREATMENTS. THE TISSUE BEING FIRED UPON WAS STANDARD, HEALTHY TISSUE, NOT INFLAMED OR THIN/FRIABLE. THE PATIENT WAS STABLE AND DOING WELL AS OF POST-OP DAY 2. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. 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 ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID RESECTION PROCEDURE, THE ANASTOMOSIS FAILED THE LEAK TEST. THE CASE WAS CONVERTED TO AN OPEN PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R