BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8703591 · Received June 17, 2019

    Report

    Report Number
    3005075853-2019-19778
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    January 1, 2009
    Report Date
    May 24, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2009. BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS THROUGH A JOURNAL ARTICLE. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED AND IT IS UNKNOWN IF THE EVENTS HAVE BEEN PREVIOUSLY REPORTED. THEREFORE, ONE MEDWATCH SENT. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: OBSERVATIONAL STUDY ON GRADE-DEPENDENT TREATMENT FOR HEMORRHOIDAL DISEASE: A SINGLE CENTER EXPERIENCE. AUTHOR(S): F. AIGNER; A. SCHWAMBERGER; H. FRITSCH, R. MARGREITER, F. CONRAD, H. BONATTI. CITATION: EUR SURG (2009) 41/1: 40¿47; DOI 10.1007/S10353-009-0445-1. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO RETROSPECTIVELY EVALUATE A LARGE SERIES OF PATIENTS REFERRED TO A COLOPROCTOLOGICAL UNIT DURING A 4.5-YEAR PERIOD. FROM JUL2001 TO DEC2005, 661 PATIENT WITH HEMORRHOIDAL DISEASE WERE TREATED CONSERVATIVELY (N=281), WITH RUBBER BAND LIGATION (RBL) (N=219), HEMORRHOIDAL ARTERY LIGATION (HAL) (N=7), STAPLED HEMORRHOIDOPEXY (SH) (N=110), SCLEROTHERAPY (N=15) AND OPEN HEMORRHOIDECTOMY (OH) (N=36). IN SH GROUP, PPH 03 CIRCULAR STAPLER (ETHICON) WAS USED TO PERFORM THE PROCEDURE. POSTOPERATIVE COMPLICATIONS IN SH GROUP INCLUDED PAIN (N=12), BLEEDING (N=24 [WHICH INCLUDED (B)(6) FEMALE PATIENT]), ANAL STRICTURE (N=6) WHICH WAS SUCCESSFULLY TREATED BY LONG-TERM SELF-DILATATION AND WAS OBSERVED ONLY IN TWO PATIENT AT THE END OF FOLLOW-UP, FECAL INCONTINENCE (FI) (N=18), RECURRENCE (N=11) WHICH WAS TREATED WITH RBL (N=6), OH (N=3) AND HAL (N=1), AND ACUTE ANAL FISSURE (N=2). AT DISCHARGE, OUTCOMES IN SH GROUP INCLUDED URGENCY (N=38 WHICH INCLUDED THE (B)(6) FEMALE PATIENT, (B)(6) FEMALE PATIENT AND (B)(6) FEMALE PATIENT) AND RESIDUAL PILES (N=8). THE DEVELOPMENT OF FI IS MULTIFACTORIAL AND A CONSEQUENCE OF HEMORRHOIDAL DISEASE RATHER THAN A CAUSE. THE HIGHER INCIDENCE OF FI AFTER SH MAY BE EXPLAINED BY THE REDUCED RECTAL CAPACITY AND THE EXCISION OF HIGHLY SENSITIVE RECTAL MUCOSA. PATIENTS WHO UNDERWENT SH WERE MORE LIKELY TO COMPLAIN ABOUT FECAL URGENCY THAN WERE THOSE UNDERGOING OH. THIS MIGHT BE EXPLAINED BY THE DISTURBANCE IN RECTAL CAPACITY AND SENSITIVITY AFTER CIRCULAR RESECTION OF A MUCOSAL RING DURING SH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499416 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention