BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 29MM CURVED

    MDR report key: 3983073 · Received August 6, 2014

    Report

    Report Number
    3005075853-2014-05487
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 21, 2014
    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
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF FURTHER DETAILS ARE RECEIVED AND/OR DEVICE IS RECEIVED AND ANALYZED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION: IS THE DEVICE AVAILABLE FOR RETURN? YES. DID THE DEVICE CUT? YES. IF THE DEVICE CUT WAS THE CUT LINE FULLY CIRCUMFERENTIAL AROUND THE TARGET TISSUE? YES. WERE THE DONUTS COMPLETE? YES. WHAT WAS THE APPEARANCE OF THE STAPLES THAT WERE DEPLOYED ON THE TISSUE? MOST OF THEM PRESENTED MALFORMED STAPLES, IN A U-SHAPE, MORE OPEN THAN CLOSED. WERE THERE ANY STAPLES SEEN IN THE SURGICAL FIELD? SOME OF THEM WERE LOOSEN UP FROM THE ANASTOMOSIS, THE ONES IN U- SHAPE MENTIONED ABOVE. HOW WAS THE CASE COMPLETED? HAD TO DO A HARTMANN´S PROCEDURE. WHAT IS THE CURRENT STATUS OF THE PATIENT? PATIENT HAS BEEN RELEASED; SURGEON INDICATED PATIENT TO RETURN IN THREE MONTHS IN ORDER TO EVALUATE THE POSSIBILITY TO REVERSE THE COLOSTOMY.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO, THE SURGEON MADE THE SAME STRENGTH AS ALWAYS. DID THE DEVICE REQUIRE ONE OR TWO HANDED OPERATION? THE DEVICE WAS USED BY ONE HAND WHEN FIRING. DID THE INDICATOR MOVE AS EXPECTED DURING CLOSURE? NO, THE INDICATOR DIDN´T GO TILL THE END. HOW WAS THE PURSE STRING PLACED, BY HAND OR WITH AN ASSIST DEVICE? IF AN ASSIST DEVICE, WHAT PRODUCT? IT WAS PLACED BY HAND. WERE THERE ANY PURSE STRING ISSUES? NO. WHO DID THE PURSE STRING STEP? THE SAME SURGEON. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IF YES, HOW MANY COUNTER-CLOCKWISE REVOLUTIONS WERE USED TO OPEN THE DEVICE? NO DIFFICULTIES WERE PRESENTED DURING THE REMOVAL. THE ANALYSIS RESULTS FOUND THAT THE CDH29A 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. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW RECTAL PROCEDURE: RECTAL ANASTOMOSIS WITH THE DEVICE. THE DEVICE WAS INTRODUCED THROUGH THE RECTUM AND THE TIP WAS CLOSED TO DO THE ANASTOMOSIS AT THE CORRECT RANGE AND THE SURGEON SHOT THE DEVICE. THE SURGEONS EXPLAINED THAT THEY DID NOT HEAR A RUPTURE OF THE PLASTIC (THE PLASTIC THAT AFTER THE SHOT EXIT WITH THE RINGS OF TISSUE). THEY OPENED THE DEVICE AND INTRODUCED A SOLUTION TO CHECK THE ANASTOMOSIS AND THEN THEY REALIZED THAT THE DEVICE FAILED, THE TISSUE WAS ONLY SUPPORTED WITH A COUPLE OF STAPLES FROM ONE SIDE AND THESE STAPLES FINALLY RELEASED THE TISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460993 ILS 29MM CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4ED6X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention