BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITE RELOAD

    MDR report key: 2143252 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02671
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RETURNED. THE ANALYSIS FOUND THAT ONE ECR60W RELOAD WAS RECEIVED FULLY FIRED. AFTER FURTHER ANALYSIS THE CARTRIDGE PAN WAS NOTED TO BE BENT UPWARD ON THE PROXIMAL RIGHT SIDE. THE DAMAGE TO THE PAN IS UNRELATED TO THE REPORTED EVENT. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOAD. ALTHOUGH NO CONCLUSION COULD BE REACH ON WHAT CAUSED THE REPORTED EVENT OR THE DAMAGE TO THE PAN WITH THE INFORMATION PROVIDED, 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. EVENT COULD NOT BE CONFIRMED AS NO DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE THE SURGEON FIRED THE STAPLER ACROSS THE JEJUNUM. AFTER FURTHER INSPECTION OF THE STAPLE LINE THE SURGEON OBSERVED THAT THE STAPLER HAD FIRED AND CUT COMPLETELY HOWEVER THE MIDDLE OF THE STAPLE LINE HAD MALFORMED STAPLES WITH OPEN ENDS PRESENT. THE SURGEON OVER SEWED WITH SUTURE AND REPLACED THE RELOAD WITH A NEW WHITE CARTRIDGE AND COMPLETED THE PROCEDURE. RELOAD IS RETURNING FOR ANALYSIS. DEVICE WAS DISCARDED. ON WHAT TISSUE TYPE WAS THE DEVICE USED? STOMACH AT WHAT LOCATION ON THE TISSUE? JEJUNUM. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 3RD. DURING WHICH STROKE DID THE EVENT OCCUR? COMPLETE WITH FIRING. WHAT COLOR CARTRIDGE WAS BEING USED? WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WHITE. WAS BUTTRESSING MATERIAL UTILIZED? NO. IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NEAR. WERE ANY UNEXPECTED NOISES HEARD? NO. IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITE RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1 LONG60A