BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*MULTIFEED STAPLER

    MDR report key: 8903012 · Received August 16, 2019

    Report

    Report Number
    3005075853-2019-21315
    Event Type
    Injury
    Date Received
    August 16, 2019
    Report Date
    August 1, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K913469
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. BATCH # UNKNOWN. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: RANDOMIZED CLINICAL TRIAL COMPARING 5-YEAR RECURRENCE RATE AFTER LAPAROSCOPIC VERSUS SHOULDICE REPAIR OF PRIMARY INGUINAL HERNIA AUTHOR(S): D. ARVIDSSON; F. H. BERNDSEN; L. G. LARSSON; C.-E. LEIJONMARCK; G. RIMBACK; C. RUDBERG; S. SMEDBERG; L. SPANGEN; A. MONTGOMERY. CITATION: BRITISH JOURNAL OF SURGERY 2005; 92: 1085¿1091; DOI: 10.1002/BJS.5137. THE AIM OF THIS STUDY WAS TO COMPARE THE 5-YEAR RECURRENCE RATES AFTER SHOULDICE AND LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL PATCH (TAPP) REPAIR FOR PRIMARY INGUINAL HERNIA. BETWEEN FEBRUARY 1993 AND MARCH 1996, 1183 PATIENTS WITH PRIMARY INGUINAL HERNIAS WERE RANDOMIZED INTO TWO GROUPS IN WHICH 920 PATIENTS COMPLETED THE 5 -YEAR FOLLOW UP: IN TAPP GROUP (N=454; MEAN AGE 51.2 YEARS) AND IN SHOULDICE GROUP (N=466; MEAN AGE=52.2). IN THE TAPP OPERATION, THE PERITONEUM WAS OPENED ABOVE THE INTERNAL RING AND THE PREPERITONEAL SPACE WAS ENTERED. AFTER DISSECTION OF THE HERNIA SAC AND PREPARATION OF COOPER¿S LIGAMENT AND THE TRIANGLE OF DOOM, A 7 X 12 CM PROLENE MESH (ETHICON) WAS INSERTED AND STAPLED IN PLACE USING AN ENDOSCOPIC STAPLER (EMS MULTIFEED STAPLEGUN, ETHICON). CARE WAS TAKEN NOT TO USE STAPLES BELOW THE ILIOPUPIC TRACT. THE PERITONEUM WAS STAPLED IN PLACE TO COVER THE MESH COMPLETELY. IN TAPP REPAIR, RECURRENCE (N=30) WAS OBSERVED OF WHICH, THE PATIENTS WERE EITHER REOPERATED OR HAD A POSITIVE HERNIOGRAM. IN THIS RANDOMIZED MULTICENTRE TRIAL THERE WAS NO DIFFERENCE IN THE 5-YEAR RECURRENCE RATE AFTER LAPAROSCOPIC TAPP AND SHOULDICE REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696421 ENDOPATH*MULTIFEED STAPLER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention