BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8843568 · Received July 30, 2019

    Report

    Report Number
    3005075853-2019-20903
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    January 1, 2005
    Report Date
    July 11, 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 · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2005. 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. (B)(4).

    Description of Event or Problem · 1

    TITLE: PROSPECTIVE RANDOMISED CLINICAL TRIAL OF SINGLE VERSUS DOUBLE PURSE-STRING STAPLED MUCOSECTOMY IN THE TREATMENT OF PROLAPSED HAEMORRHOIDS. AUTHORS: FRANCISCO PÉREZ-VICENTE, ANTONIO ARROYO, PILAR SERRANO, FERNANDO CANDELA, ANA SANCHEZ AND RAFAEL CALPENA. CITATION: INT J COLORECTAL DIS (2006) 21: 38¿43; DOI 10.1007/S00384-004-0720-3; PUBLISHED ONLINE: 21 APRIL 2005. THIS PROSPECTIVE RANDOMIZED CLINICAL TRIAL AIMED TO COMPARE THE OUTCOMES AFTER SINGLE PURSE-STRING CSM VERSUS DOUBLE PURSE-STRING CSM. BETWEEN MAY 2000 AND JUNE 2002, ONE HUNDRED CONSECUTIVE PATIENTS (MALE N=63, FEMALE N=37, MEAN AGE 50.70 YEARS) WERE RANDOMIZED TO SINGLE PURSE-STRING CSM (GROUP 1, N=50, MALE N=34, FEMALE N=16, WITH MEAN AGE 49.50 YEARS) VERSUS DOUBLE PURSE-STRING CSM (GROUP 2, N=50, MALE N=29, FEMALE N=21, WITH MEAN AGE 51.92 YEARS. THE OPERATION WAS CARRIED OUT ACCORDING TO THE TECHNIQUE INITIALLY DESCRIBED BY LONGO UTILIZING A 33-MM CIRCULAR STAPLING DEVICE (PPH 33-01, ETHICON ENDOSURGERY). COMPLICATIONS IN THE SINGLE PURSE GROUP INCLUDED ANASTOMOTIC BLEEDING REQUIRING TRANSFIXIVE SUTURE (N=14), STAPLE SUTURE DEFECT (N=2), PAIN ON DEFECATION (N=14), FREQUENT BLEEDING POSTOPERATIVE (N=7), DAILY BLEEDING POSTOPERATIVE (N=2) IN WHICH ONE PATIENT WAS TAKEN BACK TO THE OPERATING THEATRE WITHIN THE FIRST 12 POSTOPERATIVE HOURS; INCONTINENCE (N=7) WHICH SPONTANEOUSLY REVERSED WITH NO TREATMENT, PERSISTENT PAIN (N=3) IN WHICH ONE PATIENT HAD REMOVAL OF SEVERAL STAPLES THAT WERE TOO CLOSE TO THE DENTATE LINE AND RESIDUAL PROLAPSE/RECURRENCE (N=2) IN WHICH ONE PATIENT UNDERWENT ANOTHER CSM AND THE OTHER PATIENT UNDERWENT A MILLIGAN ¿ MORGAN PROCEDURE. IN THE DOUBLE PURSE GROUP, COMPLICATIONS INCLUDED ANASTOMOTIC BLEEDING REQUIRING TRANSFIXIVE SUTURE (N=23), STAPLE SUTURE DEFECT (N=1), PAIN ON DEFECATION (N=9), FREQUENT BLEEDING POSTOPERATIVE (N=7) AND INCONTINENCE (N=5) WHICH SPONTANEOUSLY REVERSED WITH NO TREATMENT. IN CONCLUSION, DOUBLE PURSE-STRING CSM RESECTS A GREATER DOUGHNUT AND INCREASES THE DISTANCE OF THE STAPLE SUTURE FROM THE DENTATE LINE IN COMPARISON TO SINGLE PURSE-STRING CSM, IMPROVING RESULTS IN TERMS OF EARLY POSTOPERATIVE PAIN. LARGER SERIES SHOULD BE NECESSARY TO ASSERT WHETHER RECURRENCE IS LOWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634762 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention