BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH)

    MDR report key: 1871439 · Received October 15, 2010

    Report

    Report Number
    3005075853-2010-05893
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Report Date
    September 6, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K030925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MISALIGNED ANVIL AND DAMAGED KNIFE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE ANVIL SHAFT BENT, 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, CAUSING THE STAPLES TO MALFORM. WHILE NO CONCLUSION COULD BE REACHED AS WHAT MAY HAVE CAUSED THE ANVIL TO BECOME OFF CENTER, IT IS POSSIBLE THAT EXCESSIVE THICK TISSUE UNEVENLY LOADED WAS ON THE DEVICE WHILE ATTEMPTING TO FIRE, RESULTING IN AN INCOMPLETE STAPLE LINE. FOR MORE INFORMATION, PLEASE REFERENCE THE INSTRUCTIONS FOR USE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED AND THE DEVICE WAS TESTED FOR FUNCTIONALITY; IT FIRED AND THE STAPLE LINE WAS COMPLETE. HOWEVER, THE STAPLES WERE NOT FORMED PROPERLY DUE TO THE BENT SHAFT, AND THE WASHER CUT WAS NOT A PERFECT CIRCLE DUE TO THE DAMAGED KNIFE. 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. 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 STARR PROCEDURE, THE INSTRUMENT CUT AND STAPLED ONLY HALF. NO FURTHER INFORMATION IS AVAILABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4RP88

    Patients

    Seq Age Sex Outcome Treatment
    1