BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8813475 · Received July 22, 2019

    Report

    Report Number
    3005075853-2019-20627
    Event Type
    Injury
    Date Received
    July 22, 2019
    Report Date
    June 28, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2008. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: TREATMENT OF HEMORRHOIDS IN DAY SURGERY: STAPLED HEMORRHOIDOPEXY VS MILLIGAN¿MORGAN HEMORRHOIDECTOMY. AUTHORS: VITO MARIA STOLFI, PIERPAOLO SILERI, CHIARA MICOSSI, ISABELLA CARBONARO, MARCO VENZA, PAOLO GENTILESCHI, PIERO ROSSI, ALESSANDRO FALCHETTI, ACHILLE GASPARI. CITATION: J GASTROINTEST SURG (2008); 12:795¿801. DOI 10.1007/S11605-008-0497-8. THE AIM OF THIS STUDY WAS TO COMPARE THE LONGO STAPLED HEMORRHOIDOPEXY (SH) AND THE MILLIGAN¿MORGAN HEMORRHOIDECTOMY (MMH). BETWEEN JANUARY 2002 AND JUNE 2006, 171 CONSECUTIVE PATIENTS (102 MALE AND 69 FEMALE) WERE ENROLLED IN THIS STUDY TO BE TREATED ON A DAYCARE BASIS. TWO GROUPS WERE CREATED: IN SH GROUP, 95 PATIENTS WERE OPERATED ON USING PPH-01 KIT (ETHICON) AND IN MMH GROUP, 76 PATIENTS WERE OPERATED ON USING A STANDARD OPEN HEMORRHOIDECTOMY TECHNIQUE. REPORTED COMPLICATIONS IN THE SH GROUP INCLUDED PAIN (N-?) IN WHICH 4 PATIENTS REQUIRED OBSERVATION OVERNIGHT, POSTOPERATIVE PAIN IN THE FIRST 2 DAYS (N-93), POSTOPERATIVE PAIN IN DAYS 3-8 (N-82) AND POSTOPERATIVE PAIN IN 8 DAYS (N-82), SECRETION (N-?), ITCHING (N-?), ANAL FISSURE (N-6), ANAL STRICTURE (N-2), URGENCY (N-5), SKIN TAGS (N-12), ANAL HEMORRHAGE (N-3), RECURRENCE OF PROLAPSE (N-7) AND POSTOPERATIVE COMPLICATIONS (N-3) WHICH REQUIRED ADMISSION FOR 2 TO 4 DAYS. IN CONCLUSION, THIS STUDY CONFIRMS THAT SH IS ASSOCIATED WITH LESS POSTOPERATIVE PAIN AND SHORTER POSTOPERATIVE SYMPTOMS, COMPARED WITH MMH. SH MAY BE A VIABLE ADDITION TO THE THERAPY FOR HEMORRHOIDS WITH SOME ADVANTAGES IN EARLY POSTOPERATIVE PAIN AND SOME DISADVANTAGES IN POSTOPERATIVE COMPLICATIONS AND COSTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607533 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention