BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8723002 · Received June 21, 2019

    Report

    Report Number
    3005075853-2019-19938
    Event Type
    Injury
    Date Received
    June 21, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036012993
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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: PROSPECTIVE RANDOMIZED CLINICAL TRIAL COMPARING TWO DIFFERENT CIRCULAR STAPLERS FOR MUCOSECTOMY IN THE TREATMENT OF HEMORRHOIDS. AUTHORS: ANTONIO ARROYO, PHD, FRANCISCO PEREZ-VICENTE, MD, ELENA MIRANDA, MD, ANA SANCHEZ, MD, PILAR SERRANO, PHD, FERNANDO CANDELA, PHD, ISRAEL OLIVER, PHD, RAFAEL CALPENA, PHD. CITATION: WORLD J SURG (2006) 30: 1305¿1310. DOI: 10.1007/S00268-005-0222-7. THE AIM OF THIS PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL WAS TO COMPARE THE INTRAOPERATIVE AND SHORT TERM POSTOPERATIVE MORBIDITY OF CIRCULAR STAPLED MUCOSECTOMY (CSM) WITH PPH33-01 VERSUS PPH33-03 IN THE TREATMENT OF CHRONIC HEMORRHOIDS. SIXTY CONSECUTIVE PATIENTS WERE RANDOMIZED TO GROUP 1 (N ¿ 30; 24 MALE AND 6 FEMALE; AGE 49.50 YEARS) WHICH WILL USE PPH-01 (ETHICON) OR GROUP 2 (N-30; 19 MALE AND 11 FEMALE; AGE 51.92 YEARS) USING PPH-03 STAPLER (ETHICON). REPORTED COMPLICATIONS IN GROUP 1 INCLUDED ANASTOMOTIC BLEEDING REQUIRING SUTURE LIGATION (N-15), TENESMUS OR DISCOMFORT ON DEFECATION (N-15), POSTOPERATIVE RECTAL BLEEDING (N-30) IN WHICH 1 PATIENT WAS TAKEN BACK TO THE OPERATING ROOM WITHIN THE FIRST 12 POSTOPERATIVE HOURS, INCONTINENCE (N-3), GRANULOMAS (N-6), AND PERSISTENT PAIN (N-1) THAT RESOLVED WITHIN THE NEXT 3 MONTHS. THIS PATIENT REQUIRED MAINTENANCE OF DAILY POSTOPERATIVE ANALGESICS DURING THAT TIME. IN GROUP 2, REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC BLEEDING REQUIRING SUTURE LIGATION (N-4), TENESMUS OR DISCOMFORT ON DEFECATION (N-2), POSTOPERATIVE RECTAL BLEEDING (N-30), INCONTINENCE (N-3), AND PERSISTENT PAIN (N-1). IN CONCLUSION, CSM WITH PPH33-03 DECREASES THE RISK OF IMMEDIATE COMPLICATIONS AND MAY ALLOW IMPLANTATION WITH GREATER SAFETY AS A DAY SURGERY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515474 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1