BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8721907 · Received June 21, 2019

    Report

    Report Number
    3005075853-2019-19915
    Event Type
    Injury
    Date Received
    June 21, 2019
    Report Date
    May 27, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. 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: STAPLED HEMORRHOIDOPEXY: RESULTS AT 10-YEAR FOLLOW-UP AUTHORS: GABRIELE BELLIO, M.D.; ARIANNA PASQUALI, M.D.; MICHELE SCHIANO DI VISCONTE, M.D. CITATION: DIS COLON RECTUM 2018; 61: 491¿498. DOI: 10.1097/DCR.0000000000001025. THE AIM OF THIS STUDY WAS TO EVALUATE CLINICAL OUTCOMES AND PATIENT SATISFACTION AFTER STAPLED HEMORRHOIDOPEXY (SH) AT 10-YEAR FOLLOW-UP. THIS WAS A RETROSPECTIVE COHORT ANALYSIS CONDUCTED ON PROSPECTIVELY COLLECTED DATA ON 86 CONSECUTIVE PATIENTS (45 MALE AND 41 FEMALE PATIENTS; AGE RANGE: 31 TO 74 YEARS OLD) TREATED WITH STAPLED HEMORRHOIDOPECY FOR GRADE 3 HEMORRHOIDAL PROLAPSE BETWEEN JANUARY AND DECEMBER 2006. DURING THE SURGICAL TECHNIQUE, ONE CIRCUMFERENTIAL PURSESTRING SUTURE WAS PLACED IN THE RECTAL WALL, THROUGH THE MUCOSA AND SUBMUCOSA, ¿2 CM ABOVE THE HEMORRHOIDAL APEX. A PPH-03 33MM CIRCULAR STAPLER (ETHICON) WAS INSERTED, CLOSED, AND FIRED. IN FEMALE PATIENTS, IT WAS ALWAYS VERIFIED BEFORE FIRING THE STAPLER THAT THE POSTERIOR WALL OF THE VAGINA WAS NOT TRAPPED INTO THE INSTRUMENT. IMMEDIATE POST-OPERATIVE COMPLICATIONS INCLUDED SUTURE LINE BLEEDING (N-2) WHICH REQUIRED RE-OPERATION AND CONTROLLED WITH RESORBABLE STITCHES. AT 1 MONTH FOLLOW-UP, REPORTED COMPLICATIONS INCLUDED BLEEDING (N-5), SOILING (N-3), PAIN (N-6), URGE TO DEFECATE (N-46), AND LEAKAGE (N-9) WHICH REQUIRED ANAL ULTRASOUND IN 2 PATIENTS WITH LIQUID LEAKAGE. AT 10 YEARS FOLLOW-UP, REPORTED COMPLICATIONS INCLUDED BLEEDING (N-29) WHICH REQUIRED DRUG THERAPY IN 25 PATIENTS, SOILING (N-7), PAIN (N-18), URGE TO DEFECATE (N-34) IN WHICH 1 PATIENT WHO WAS AFFECTED BY AN INTRACTABLE URGE TO DEFECATE REQUIRED SACRAL NEUROMODULATION, LEAKAGE (N-6), SKIN TAGS (N-24) WHICH REQUIRED SURGICAL REMOVAL IN 8 PATIENTS, HEMORRHOIDAL PROLAPSE (N-9) WHICH REQUIRED RUBBER BAND LIGATION, RECURRENT HEMORRHOIDAL PROLAPSE (N-22), MUCOSAL-HEMORRHOIDAL PROLAPSE RECURRENCE (N-30), HEMORRHOIDAL THROMBOSIS (N-12), AND STAPLED HEMORRHOIDOPEXY SYNDROME (N-2). SH IS A RENOWNED TECHNIQUE TO TREAT MUCOSAL¿HEMORRHOIDAL PROLAPSE THAT HAS FOUND GOOD CONSENSUS THANKS TO THE ADVANTAGES DEMONSTRATED IN SHORT-TERM OUTCOMES. THIS STUDY SHOWED THAT TRADITIONAL SH, AS PROPOSED BY LONGO IS ASSOCIATED WITH A HIGH RECURRENCE RATE AND POOR PATIENT SATISFACTION AT 10-YEAR FOLLOW-UP. THE RESULTS OF THIS STUDY SUPPORT THAT SH FOR GRADE 3 HEMORRHOIDS SHOULD BE TAILORED ON THE VOLUME OF HEMORRHOIDAL PROLAPSE. IF THE PROLAPSE EXCEEDS HALF OF THE CIRCULAR ANAL DILATATOR, THE DOUBLE-STAPLER TECHNIQUE OR A HIGH-VOLUME DEVICE SHOULD BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516285 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1