BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8721874 · Received June 21, 2019

    Report

    Report Number
    3005075853-2019-19911
    Event Type
    Injury
    Date Received
    June 21, 2019
    Report Date
    June 24, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036012993
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. BATCH # UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE : SHORT- AND LONG-TERM RESULTS OF HARMONIC SCALPEL HEMORRHOIDECTOMY VERSUS STAPLER HEMORRHOIDOPEXY IN TREATMENT OF HEMORRHOIDAL DISEASE. AUTHOR : YUSUF BILGIN, SEMIH HOT*, _ILHAMI SOYKAN BARLAS, ARZU AKAN, YAVUZ ERYAVUZ CITATION: ASIAN JOURNAL OF SURGERY. 2015; 38: 214E219. DOI: HTTP://DX.DOI.ORG/10.1016/J.ASJSUR.2014.09.004. IN THIS PROSPECTIVE RANDOMIZED STUDY, THE AIM IS TO COMPARE THE SHORT AND LONG-TERM RESULTS OF HARMONIC SCALPEL HEMORRHOIDECTOMY (HSH) AND STAPLER HEMORRHOIDOPEXY (SH) METHODS IN THE SURGICAL TREATMENT OF GRADE III AND GRADE IV HEMORRHOIDAL DISEASE. A TOTAL OF 99 CONSECUTIVE PATIENTS DIAGNOSED WITH GRADE III OR GRADE IV INTERNAL HEMORRHOIDAL DISEASE WERE INCLUDED IN THE STUDY. PATIENTS WERE RANDOMIZED TO HSH (N-48; MEAN AGE: 44.9 YEARS; 28 MALE AND 20 FEMALE PATIENTS) OR SH (N-51; MEAN AGE: 44.3 YEARS; 32 MALE AND 19 FEMALE PATIENTS) TREATMENTS. DURING THE SURGICAL PROCEDURE IN THE HSH GROUP, HARMONIC SCALPEL (ETHICON) SEALS BLEEDING VESSELS AND FORMS PROTEIN COAGULUM. WHEN USED IN HEMORRHOIDECTOMY, THIS METHOD MINIMIZES BLEEDING OF LARGE HEMORRHOIDS AND DECREASES OPERATIVE TIME. IT WAS REPORTED THAT SUTURES WERE NOT USED. DURING THE SURGICAL PROCEDURE IN THE SH GROUP, PPH01 KIT (ETHICON), A PURSE-STRING SUTURE ANOSCOPE (PSA), A SUTURE THREADER, AND A 33-MM HEMORRHOIDAL CIRCULAR STAPLER, WAS USED. THE PURSESTRING WAS DONE BETWEEN 3 CM AND 4 CM ABOVE THE DENTATE LINE; THE PURSE-STRING WAS COMPLETED WITH SIX TO EIGHT STITCHES, WHICH INCLUDED ONLY THE MUCOSAL AND SUBMUCOSAL LAYERS, AND HEMOSTATIC STITCHES USING A VICRYL 3-0 (ETHICON) SUTURE ON A ROUND BODY WERE USED IN CASE OF BLEEDING. IN THE HSH GROUP, REPORTED SHORT-TERM COMPLICATION INCLUDED BLEEDING (N-5); REPORTED LONG-TERM COMPLICATION INCLUDED RECURRENCE (N-1). IN THE SH GROUP, REPORTED SHORT-TERM COMPLICATIONS INCLUDED POST-OPERATIVE PAIN (N-37), WOUND PROBLEMS (N-8), AND BLEEDING (N-8); REPORTED LONG-TERM COMPLICATIONS INCLUDED RECURRENCE (N-7) AND PERIANAL FISTULA (N-1). IT WAS CONCLUDED THAT THE HSH AND SH ARE BOTH SAFE AND EFFECTIVE METHODS FOR SURGICAL TREATMENT OF GRADE III AND GRADE IV HEMORRHOIDAL DISEASE. IN THE STUDY, THE HSH METHOD WAS DETERMINED TO BE SAFER, EASIER, AND FASTER TO PERFORM, AND ASSOCIATED WITH FEWER LONG-TERM RECURRENCES THAN THE SH METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515382 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown