BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8845188 · Received July 31, 2019

    Report

    Report Number
    3005075853-2019-20912
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    January 1, 2005
    Report Date
    July 11, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036012993
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2005. 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 HEMORRHOIDOPEXY VS. DIATHERMY EXCISION FOR FOURTH-DEGREE. HEMORRHOIDS: A RANDOMIZED, CLINICAL. TRIAL AND REVIEW OF THE LITERATURE. AUTHOR : HECTOR ORTIZ, JOSE MARXO , PEDRO ARMENDARIZ, MARIO DE MIGUEL. CITATION: DIS COLON RECTUM (2005); 48: 809¿815. DOI: 10.1007/S10350-004-0861-Z. THE AIM OF THIS PROSPECTIVE STUDY WAS TO COMPARE THE RESULTS OF STAPLED HEMORRHOIDOPEXY WITH THOSE OF CONVENTIONAL DIATHERMY EXCISION FOR CONTROLLING SYMPTOMS IN PATIENTS WITH FOURTH-DEGREE HEMORRHOIDS. BETWEEN JANUARY 2001 AND FEBRUARY 2002, 31 CONSECUTIVE PATIENTS WITH FOURTH-DEGREE HEMORRHOIDS WERE ENROLLED IN THE STUDY. THE PATIENTS WERE RANDOMIZED INTO TWO GROUPS: 15 PATIENTS (8 MALE AND 7 FEMALE; MEAN AGE: 47 YEARS; AGE RANGE: 28-69 YEARS) UNDERWENT STAPLED HEMORRHOIDOPEXY AND 16 PATIENTS (11 MALE AND 5 FEMALE; MEAN AGE: 49 YEARS; AGE RANGE: 32-69 YEARS) UNDERWENT DIATHERMY EXCISION. IN STAPLED HEMORRHOIDOPEXY, THE STAPLING PROCEDURE WAS PERFORMED ACCORDING TO THE TECHNIQUE DESCRIBED BY LONGO. THE PPH01 STAPLING GUN (ETHICON) WAS OPENED TO ITS MAXIMUM POSITION AND INTRODUCED THROUGH THE ANUS. A PURSESTRING SUTURE WAS TIED ON THE STAPLER SHAFT, AND THE HEAD OF THE INSTRUMENT WAS CLOSED ON THE ANVIL, INCORPORATING THE MUCOSAL AND SUBMUCOSAL TISSUE IN THE PURSESTRING SUTURE IN THE HEAD OF THE GUN. THE STAPLER WAS THEN FIRED AND GENTLY WITHDRAWN. REPORTED COMPLICATIONS INCLUDED MINOR STAPLE-LINE BLEEDING (N-11) IN WHICH PATIENTS REQUIRED HEMOSTATIC SUTURES, EXTERNAL HEMORRHOIDAL THROMBOSIS (N-1) WHICH REQUIRED MEDICAL TREATMENT, FECAL IMPACTION (N-1) WHICH REQUIRED MEDICAL TREATMENT, PAIN DURING THE FIRST 14 DAYS (N-?), RECURRENT PROLAPSE (N-8) IN WHICH 5 PATIENTS RESPONDED WELL TO A LATER CONVENTIONAL DIATHERMY HEMORRHOIDECTOMY, PERSISTENCE OF ITCHING (N-6), TENESMUS (N-6), HEMORRHAGE (N-1), SKIN TAGS (N-10) AND URGENCY (N-2). IN CONCLUSION, STAPLED HEMORRHOIDOPEXY WAS NOT EFFECTIVE AS A DEFINITIVE CURE FOR THE SYMPTOMS OF PROLAPSE AND ITCHING IN PATIENTS WITH FOURTH-DEGREE HEMORRHOIDS. THE CONVENTIONAL DIATHERMY HEMORRHOIDECTOMY SHOULD CONTINUE TO BE RECOMMENDED IN PATIENTS WITH SYMPTOMATIC, PROLAPSED, IRREDUCIBLE PILES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642297 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention