BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2182039 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03055
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 26, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K030925
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED. PATIENT'S HOSPITALIZATION WAS EXTENDED TO (B)(6). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFORMATION, THE MANUFACTURING RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MANUFACTURING OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT 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. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. 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, DURING AN ANTERIOR RESECTION, THE SURGEON CLOSED AND ACTIONED THE DEVICE WHICH CUT BUT IT DID NOT APPLY STAPLES. WHEN THE DEVICE WAS EXTRACTED, THERE WAS A SEVERE HEMORRHAGE AND LOOPS OF SIGMA WERE VISIBLE THROUGH THE SECTION DONE BY THE DEVICE. THE CASE WAS CARRIED OUT BY APPLYING MANUAL SUTURES BUT AS A CONSEQUENCE THE CASE WAS PROLONGED AND HOSPITALIZATION WAS EXTENDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 H43Y1E

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| R