BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 2232136 · Received September 2, 2011

    Report

    Report Number
    3005075853-2011-03146
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE ANVIL SHROUD DAMAGED, WITH NO STAPLES PRESENT AND WITH THE BREAKAWAY WASHER CUT, INDICATING THAT THE DEVICE HAD BEEN COMPLETELY FIRED. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED AND THE DEVICE WAS TESTED FOR FUNCTIONALITY AND 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. PLEASE REFERENCE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION NEEDED. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE ANVIL SHROUD BECAME DAMAGED, IT SHOULD BE NOTED THAT AT LEAST A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; (B)(4). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: DID THE SURGEON OPEN THE DEVICE ACCORDING TO THE IFU? THIS DID NOT WORK AND HE DECIDED TO PULL HARDER TO GET IT OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER FIRING THE DEVICE, THE DEVICE COULD NOT BE REMOVED OUT OF THE PATIENT. THE SURGEON VIOLENTLY REMOVED THE DEVICE AND OVERSTITCHED BY HAND. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1