BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PROCEDURE SET

    MDR report key: 4762258 · Received May 11, 2015

    Report

    Report Number
    3005075853-2015-02943
    Event Type
    Malfunction
    Date Received
    May 11, 2015
    Date of Event
    April 30, 2015
    Report Date
    May 5, 2015
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # L53X0N. BREAKAWAY WASHER CUT OFF CENTER. THE ANALYSIS RESULTS FOUND THAT THE PPH03 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. 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 THAT ENSURING 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 THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE DEVICE IS RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED: WHAT DEGREE OF HEMORRHOIDS DID THE PATIENT HAVE? WHAT CONFIRMATION WAS RECEIVED THAT THE DEVICE WAS FULLY FIRED? WHERE WITHIN THE GAP SETTING SCALE WAS THE ORANGE INDICATOR PRIOR TO FIRING? DID THE DEVICE STAPLE? WAS THE STAPLE LINE COMPLETE? WHAT WAS THE APPEARANCE OF THE DEPLOYED STAPLES (B-FORMATION, IRREGULAR, STRAIGHT LEGS)? DID THE DEVICE CUT? IF THE DEVICE CUT WAS THE CUT LINE FULLY CIRCUMFERENTIAL AROUND THE TARGET TISSUE? IF THE DEVICE FULLY CUT, WERE ALL TISSUE LAYERS PRESENT IN BOTH DONUTS WHEN INSPECTED?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY PROCEDURE, THE PRODUCT FAILED DURING THE CUTTING AND STAPLING. THE SURGEON MADE THE PROCEDURE MANUALLY WITH SUTURE AND MONOPOLAR BISTOURY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306128 PROXIMATE PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L92055

    Patients

    Seq Age Sex Outcome Treatment
    1