BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 2241717 · Received September 9, 2011

    Report

    Report Number
    3005075853-2011-03717
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    June 14, 2011
    Report Date
    August 8, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BREAKAWAY WASHER CUT OFF CENTER ADDITIONAL INFORMATION: FOR PRIVACY REASONS, SURGEON WILL NOT PROVIDE ADDITIONAL INFORMATION WITHOUT PATIENT APPROVAL. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE KNIFE DAMAGED; THE BREAKAWAY WASHER WAS PRESENT AND WITH AN OFF-CENTER CUT. IT APPEARS POSSIBLE THAT THE ANVIL WAS PUSHED FAR ENOUGH OFF CENTER TO RESULT IN AN OFF CENTER CUT OF THE BREAKAWAY WASHER AND DAMAGE THE KNIFE BY PRESSING IT HARD ENOUGH AGAINST THE ANVIL. THIS SITUATION NORMALLY OCCURS WHEN THE TISSUE IS NOT EVENLY DISTRIBUTED IN THE DEVICE. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE ANVIL TO BECOME OFF CENTER. IT SHOULD BE NOTED TO ENSURE THAT THE TISSUE THICKNESS IS WITHIN THE INDICATED RANGE, AND THAT IT IS EVENLY DISTRIBUTED IN THE DEVICE. EXCESS TISSUE ON ONE SIDE MAY RESULT IN UNACCEPTABLE STAPLE FORMATION AND CAN RESULT IN STAPLE LINE LEAKAGE. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED AND THE DEVICE 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLER WAS CLOSED AND THE SCALE IS WITHIN THE GREEN ZONE. HOWEVER, AFTER FIRING, THERE WAS NO CLICK SOUND HEARD AND THE SURGEON COULD NOT PULL THE FIRING TRIGGER FURTHER. WHEN THE FIRING TRIGGER WAS RELEASED, BLEEDING WAS FOUND AND THE SURGEON FOUND THAT THE TISSUE WAS NOT COMPLETELY CUT. THE SURGEON USED THE SCISSORS TO CUT INSTEAD. FINALLY, IT TOOK THE SURGEON 90 MINUTES TO SUTURE 360 DEGREES IN ORDER TO STOP THE BLEEDING. ANOTHER SURGEON WAS CALLED TO ASSIST. MOREOVER, WHEN THE PPH WAS OFF TABLE, THE SCRUB NURSE TRIED TO FIRE IT AGAIN, AND SHE HEARD A CLICK SOUND. SO, WHEN THE SAMPLE IS RECEIVED, THE WASHER IS BROKEN. LASTLY, THE SURGEON TOLD ME THAT THE PATHOLOGY REPORT SHOWED THERE WAS NO MUSCLE INVOLVED DURING THE FIRING ACTION. . ADDITIONAL INFORMATION BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TC95

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R