BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8860235 · Received August 5, 2019

    Report

    Report Number
    3005075853-2019-21050
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    January 1, 2006
    Report Date
    July 12, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036012993
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2006. 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

    IT WAS REPORTED VIA LITERATURE ENTITLED: LOW HEMORRHOIDOPEXY STAPLE LINE DOES NOT IMPROVE RESULTS AND INCREASES RISK FOR INCONTINENCE. AUTHORS: F. PIGOT, M. DAO-QUANG, A. CASTINEL, F. JUGUET, D. BOUCHARD, J. BOCKLE AND F.A. ALLAERT. CITATION: TECH COLOPROCTOL (2006) 10:329¿333; DOI 10.1007/S10151-006-0302-1; PUBLISHED ONLINE: 27 NOVEMBER 2006. THIS PROSPECTIVE STUDY AIMED TO ASSESS THE ASSOCIATION BETWEEN OUTCOME OF SH AND PATIENTS¿ CHARACTERISTICS AND PROCEDURE PARAMETERS (ASSOCIATED PROCEDURE, SUTURE LINE HEIGHT, DOUGHNUT SIZE, PRESENCE OF MALPIGHIAN TISSUE OR SMOOTH MUSCLE IN SPECIMEN). BETWEEN DECEMBER 2003 AND JUNE 2004, 68 PATIENTS WITH MEAN AGE 51 YEARS, RANGE 25-83 YEARS (MALE N=56, FEMALE N=12) UNDERWENT SH. A MUCOSAL DOUGHNUT WAS RESECTED JUST ABOVE THE APEX OF THE INTERNAL HEMORRHOIDS WITH A CIRCULAR STAPLER (PPH 01 OR 03, ETHICON ENDOSURGERY). EARLY COMPLICATIONS INCLUDED POSTOPERATIVE FISSURE (N=1) WHICH REQUIRED REOPERATION, LOCAL SEPSIS (N=2) WHICH REQUIRED OPERATION AND RECTAL BLEEDING (N=2) WHICH WAS MEDICALLY MANAGED WITHOUT BLOOD TRANSFUSION. THERE WAS PEROPERATIVE DYSFUNCTION OF THE STAPLER (N=1) WHICH WAS CORRECTED WITH MANUAL MUCOSAL ANASTOMOSIS. AT 4-WEEK FOLLOW-UP, COMPLICATIONS INCLUDED BLEEDING (N=9), PROLAPSE (N=5) AND PAIN (N=6) IN WHICH PARACETAMOL (400 MG)-DEXTROPROPOXYPHEN (30 MG) (2 PILLS TID) AND KETOPROFEN (150 MG BID) WERE PRESCRIBED. AT 32-WEEK FOLLOW UP, COMPLICATIONS INCLUDED BLEEDING (N=9), PROLAPSE (N=9) AND PAIN (N=3) IN WHICH PARACETAMOL (400 MG)-DEXTROPROPOXYPHEN (30 MG) (2 PILLS TID) AND KETOPROFEN (150 MG BID) WERE PRESCRIBED. FURTHER COMPLICATIONS INCLUDED ANAL INCONTINENCE (N=11), URGENCY (N=11), INCONTINENCE FOR LIQUID STOOL AND FLATUS (N=2) AND SOILING AND FLATUS INCONTINENCE (N=1). IN CONCLUSION, ALTHOUGH THE SUCCESS RATE OF SH MAY NOT BE INFLUENCED BY TECHNICAL VARIATIONS, RISK FOR MODERATE INCONTINENCE IS ELEVATED WHEN THE STAPLED LINE IS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654525 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention