BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8816710 · Received July 23, 2019

    Report

    Report Number
    3005075853-2019-20666
    Event Type
    Injury
    Date Received
    July 23, 2019
    Report Date
    June 26, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036012993
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2013. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: STAPLED HEMORRHOIDOPEXY VERSUS MILLIGAN-MORGAN HEMORRHOIDECTOMY IN CIRCUMFERENTIAL THIRD-DEGREE HEMORRHOIDS: LONG-TERM RESULTS OF A RANDOMIZED CONTROLLED TRIAL. AUTHOR: JONG-SUN KIM, YOGESH K. VASHIST, SABRINA THIELTGES, OLIVER ZEHLER, KARIM A. GAWAD, EMRE F. YEKEBAS, JAKOB R. IZBICKI, ASAD KUTUP. CITATION: J GASTROINTEST SURG (2013) 17:1292¿1298 / DOI 10.1007/S11605-013-2220-7. THE PURPOSE OF THIS PROSPECTIVE RANDOMIZED CONTROLLED STUDY WAS TO EVALUATE THE SHORT- AND LONG-TERM OUTCOME AFTER STAPLED HEMORRHOIDOPEXY COMPARED WITH THE MILLIGAN¿MORGAN PROCEDURE IN A HOMOGENEOUS PATIENT POPULATION WITH CIRCUMFERENTIAL THIRD-DEGREE HEMORRHOIDS. BETWEEN JUL 2000 AND SEP 2007, A TOTAL OF 122 PATIENTS WITH SYMPTOMATIC CIRCUMFERENTIAL THIRD-DEGREE HEMORRHOIDAL DISEASE WERE RANDOMLY ALLOCATED BY COMPUTER TO UNDERGO EITHER THE MILLIGAN¿MORGAN [N=61 (N=39 MALE, N=22 FEMALE, MEAN AGE 56 YEARS (RANGE 21-79))] OR STAPLING PROCEDURE [N=61 (N=47 MALE, N=14 FEMALE, MEAN AGE 53 YEARS (RANGE 32-78))]. IN SH GROUP, MUCOSECTOMY AND ANOPEXY WAS CONDUCTED USING THE PPH 01 KIT. COMPLICATIONS INCLUDED POSTOPERATIVE PAIN (N=?); BURNING/ITCHING SENSATION 4 WEEKS AFTER SURGERY (N=3); POSTOPERATIVE BLEEDING (N=3); GAS LEAKAGE (N=4) RESOLVED SPONTANEOUSLY WITHIN THE FIRST 6 MONTHS AFTER SURGERY; INTERMITTENT GAS LEAKAGE AND RECURRENCES (N=4) TREATED SUCCESSFULLY BY RBL OR REOPERATION AND RESOLVED SPONTANEOUSLY IN ALL PATIENTS; RECURRENCE RATES AFTER 5 YEARS (N=11) WHEREIN THREE WERE SUCCESSFULLY TREATED USING THE MM PROCEDURE AND THE REMAINING EIGHT WERE TREATED WITH A SINGLE OR REPEATED RBL; AND INCONTINENCE SYMPTOMS (N=2). THE RESULTS SHOW A SIMILAR RATE OF RECURRENCE IN THE LONG TERM AND SUGGEST INCREASED PATIENT COMFORT IN THE EARLY POSTOPERATIVE COURSE AFTER STAPLED HEMORRHOIDOPEXY. IN PATIENTS WITH CIRCUMFERENTIAL THIRD-DEGREE HEMORRHOIDS, STAPLED HEMORRHOIDOPEXY IS AS EFFECTIVE AS THE MILLIGAN¿MORGAN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611029 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention