BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN

    MDR report key: 8830801 · Received July 26, 2019

    Report

    Report Number
    3005075853-2019-20786
    Event Type
    Injury
    Date Received
    July 26, 2019
    Date of Event
    January 1, 2010
    Report Date
    July 2, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    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 2010. 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: STAPLED HAEMORRHOIDOPEXY: 6 YEARS¿ EXPERIENCE OF A REFERRAL CENTRE AUTHOR: S. SULTAN, N. RABAHI, I. ETIENNEY AND P. ATIENZA CITATION: THE ASSOCIATION OF COLOPROCTOLOGY OF GREAT BRITAIN AND IRELAND. COLORECTAL DISEASE (2010); 12: 921¿926. DOI:10.1111/J.1463-1318.2009.01893.X. THE AIM OF THIS STUDY IS TO PROSPECTIVELY EVALUATE THE LONG-TERM RESULTS AND ASSESS PATIENT SATISFACTION AFTER STAPLED HAEMORRHOIDOPEXY (HS). FROM JANUARY 2001 THROUGH FEBRUARY 2006, A TOTAL OF 150 PATIENTS (121 MALE AND 29 FEMALE; AGE RANGE: 21¿ 87 YEARS) WITH SYMPTOMATIC GRADE II OR III HAEMORRHOIDS UNDERWENT STAPLED HS. A MUCOSAL DOUGHNUT WAS RESECTED WITH EITHER PPH 01 OR PPH 03 CIRCULAR STAPLER (ETHICON). A RESORBABLE HAEMOSTATIC GAUZE SURGICEL (ETHICON) WAS PLACED INTO THE ANAL CANAL ON COMPLETION OF THE OPERATION. REPORTED COMPLICATIONS INCLUDED EARLY POSTOPERATIVE BLEEDING WITHIN THE FIRST 12 H (N-3) WHICH REQUIRED REINTERVENTION, LATE POSTOPERATIVE BLEEDING BETWEEN D8 AND D10 (N-4) IN WHICH 2 NEEDED TRANSFUSION, 2 NEEDED SURGICAL HEMOSTASIS, AND 2 WERE MANAGED CONSERVATIVELY WITH LOCAL AND TEMPORARY HEMOSTATIC PACKING, ANAL FISSURE (N-6) IN WHICH 1 PATIENT REQUIRED FISSURERECTOMY, HYPERTROPHIC PAPILLA (N-1) WHICH REQUIRED HYPERTROPHIC PAPILLA RESECTION, FECAL URGENCY/ ANAL INCONTINENCE (N-?) WHICH DISAPPEARED WITHIN 3 MONTHS IN ALL BUT ONE, UNEXPLAINED PAIN FOR OVER A MONTH (N-1), EXTERNAL HAEMORRHOID THROMBOSIS (N-2) WHICH WAS TREATED CONSERVATIVELY, RECTAL STENOSIS (N-1) WHICH WAS SUCCESSFULLY TREATED BY DILATATION WITH A RIGID PROCTOSCOPE, ANAL FISTULA (N-1) WHICH REQUIRED SURGERY, AND PERSISTENT OR RECURRENT SYMPTOMATIC PROLAPSE (N-8) IN WHICH THE TREATMENT CONSISTED OF RUBBER BAND LIGATION WITH GOOD RESULTS. IN CONCLUSION, STAPLED HS PROCEDURE IS EFFECTIVE AND HAS LOW MORBIDITY, HIGH PATIENT SATISFACTION AND PROVIDED GOOD LONG-TERM CONTROL OF HAEMORRHOIDAL SYMPTOMS IN THE TREATMENT OF SECOND AND THIRD-DEGREE HAEMORRHOIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626024 PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention