BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8721998 · Received June 21, 2019

    Report

    Report Number
    3005075853-2019-19922
    Event Type
    Injury
    Date Received
    June 21, 2019
    Report Date
    May 27, 2019
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    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 : A RANDOMIZED CLINICAL TRIAL COMPARING LIGASURE VERSUS STAPLED HEMORRHOIDECTOMY. AUTHOR : NUHI ARSLANI, MD, PHD, LEONARDO PATRLJ, MD, PHD,W ZORAN RAJKOVIC´, MD,Z DINO PAPES, MD,Z AND SILVIO ALTARAC, MD, PHD CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH (2012); 22:58¿61. THE AIM OF THIS STUDY WAS TO COMPARE STAPLED HEMORRHOIDECTOMY (SH) AND LIGASURE HEMORRHOIDECTOMY (LH) AND TO DETERMINE WHETHER THERE IS A SIGNIFICANT DIFFERENCE BETWEEN THE 2 IN POSTOPERATIVE COMFORT, INCIDENCE OF COMPLICATIONS, AND RECURRENCE RATES. A PROSPECTIVE RANDOMIZED CLINICAL TRIAL INCLUDED 98 PATIENTS WHO WERE SURGICALLY TREATED FOR HEMORRHOIDAL DISEASE BETWEEN 2005 AND 2008. PATIENTS WERE RANDOMLY DIVIDED INTO 2 GROUPS: 46 PATIENTS (27 MALE AND 25 FEMALE; AGE RANGE: 17-72 YEARS) WHO WERE OPERATED UPON USING SH WITH PPH 03 (ETHICON) AND 52 PATIENTS (21 MALE AND 29 FEMALE; AGE RANGE: 18-78 YEARS) WHO WERE OPERATED UPON USING LH. IN SH, THE STAPLER HEAD WAS CLOSED. THE STAPLER WAS HELD CLOSED FOR 30 SECONDS, FIRED, AND AGAIN HELD CLOSED FOR 30 SECONDS TO ENHANCE HEMOSTASIS. THE STAPLER WAS THEN OPENED AND GENTLY WITHDRAWN. REPORTED POST OPERATIVE COMPLICATIONS INCLUDED EARLY BLEEDING WITHIN 48H (N-3), LATE BLEEDING AFTER 48H (N-3), INCONTINENCE FOR GAS AND/OR STOOL (N-2), ANAL STENOSIS (N-2), RESIDUAL SKIN TAGS (N-6) AND RECURRENCE (N-5). IN CONCLUSION, SH AND LH CAN BE USED TO TREAT GRADE 3 HEMORRHOIDAL DISEASE WITH THE SAME EFFICACY. BOTH SH AND LH ARE PROBABLY EQUALLY VALUABLE TECHNIQUES IN MODERN HEMORRHOID SURGERY, ALTHOUGH LH HAS CERTAIN ADVANTAGES, AS IT CAN BE CONSIDERED MORE PATIENT FRIENDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515969 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1