BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*MULTIFEED STAPLER

    MDR report key: 8807572 · Received July 19, 2019

    Report

    Report Number
    3005075853-2019-20526
    Event Type
    Injury
    Date Received
    July 19, 2019
    Report Date
    June 25, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K913469
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: 2007. BATCH # UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: DISCOMFORT FIVE YEARS AFTER LAPAROSCOPIC AND SHOULDICE INGUINAL HERNIA REPAIR: A RANDOMIZED TRIAL WITH 867 PATIENTS. A REPORT FROM THE SMIL STUDY GROUP. AUTHORS: FRITZ H. BERNDSEN, U. PETERSSON, D. ARVIDSSON, C.-E. LEIJONMARCK, C. RUDBERG, S. SMEDBERG AND A. MONTGOMERY. CITATION: HERNIA (2007) 11:307-313: DOI 10.1007/S10029-007-0214-7. THIS RANDOMIZED MULTICENTER TRIAL AIMED TO COMPARE FIVE-YEAR RESULTS REGARDING DISCOMFORT AFTER TAPP AND SHOUDICE REPAIR AND CORRELATE EARLY POSTOPERATIVE EVENTS WITH PERSISTING DISCOMFORTS. BETWEEN FEBRUARY 1993 TO MARCH 1996, 1068 MALE PATIENTS BETWEEN 30 AND 70 YEARS WITH UNILATERAL PRIMARY INGUINAL HERNIA WERE OPERATED WITH TAPP (N=538) AND SHOULDICE (N=530). IN THE TAPP PROCEDURE, A 7CM X 12CM POLYPROPYLENE MESH (PROLENE; ETHICON, SOMERVILLE, NJ, USA) WAS INSERTED AND FIXED BY USE OF AN ENDOSCOPIC STAPLER (EMS MULTIFEED STAPLEGUN; ETHICON). COMPLICATIONS INCLUDED HEMATOMA (N=49); MILD DISCOMFORT (N=48), MODERATE DISCOMFORT (N=16) AND SEVERE DISCOMFORT (N=1) AT 1 YEAR FOLLOW UP; MILD DISCOMFORT (N=44), AND MODERATE DISCOMFORT (N=11) AT 2 YEARS FOLLOW UP; MILD DISCOMFORT (N=44), AND MODERATE DISCOMFORT (N=11) AT 3 YEARS FOLLOW UP AND MILD DISCOMFORT (N=24), MODERATE DISCOMFORT (N=12) AND SEVERE DISCOMFORT (N=1) AT 5 YEARS FOLLOW UP. IN CONCLUSION, THERE WAS NO DIFFERENCE BETWEEN LATE DISCOMFORT AT FIVE-YEAR FOLLOW UP AFTER LAPAROSCOPIC TAPP AND SHOULDICE REPAIR. DISCOMFORT WAS MOSTLY MILD AND PAIN DURING THE FIRST POSTOPERATIVE WEEK WAS A PROGNOSTIC VARIABLE FOR LATE DISCOMFORT IN SHOULDICE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603430 ENDOPATH*MULTIFEED STAPLER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1