BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8704401 · Received June 17, 2019

    Report

    Report Number
    3005075853-2019-19808
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    January 1, 2011
    Report Date
    May 27, 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

    PRODUCT COMPLAINT #: (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2011. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS THROUGH A JOURNAL ARTICLE. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED AND IT IS UNKNOWN IF THE EVENTS HAVE BEEN PREVIOUSLY REPORTED. THEREFORE, ONE MEDWATCH SENT. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: OUTCOME OF STAPLED HEMORRHOIDOPEXY VERSUS DOPPLER-GUIDED HEMORRHOIDAL ARTERY LIGATION FOR GRADE III HEMORRHOIDS. AUTHOR(S): S. AVITAL, R. ITAH, Y. SKORNICK, R. GREENBERG. CITATION: TECH COLOPROCTOL (2011) 15:267¿271 / DOI 10.1007/S10151-011-0699-Z. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE RESULTS OF THESE TWO METHODS IN TERMS OF POSTOPERATIVE PAIN, POSTOPERATIVE COMPLICATIONS, EFFECTIVENESS IN SYMPTOM CONTROL, RECURRENCE RATE, AND PATIENT SATISFACTION. FROM JAN 2005 TO DEC 2006, A TOTAL OF 114 PATIENTS, OVER 18 YEARS OF AGE, WITH SYMPTOMATIC GOLIGHER GRADE III INTERNAL HEMORRHOIDS IN AT LEAST THREE QUADRANTS UNDERWENT STAPLED HEMORRHOIDOPEXY (SH) [N=63 (N=30 FEMALE, N-33 MALE, MEAN AGE 52 ± 3.2 YEARS)] OR DOPPLER-GUIDED HEMORRHOIDAL ARTERY LIGATION (DGHAL) [N=51 (N=29 FEMALE, N=22 MALE, MEAN AGE 50 ± 73. YEARS)]. IN SH GROUP, THE PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER PPH 01 (ETHICON ENDO SURGERY) KIT WAS USED FOR ALL PATIENTS. THE CIRCULAR ANOSCOPE WAS INSERTED TO REDUCE THE PROLAPSING ANODERM AND TO ALLOW PLACEMENT OF A CIRCUMFERENTIAL PURSE STRING SUTURE 3¿4 CM ABOVE THE DENTATE LINE INTO THE MUCOSA AND SUBMUCOSA. THE STAPLER WAS THEN CLOSED AND ADVANCED INTO THE ANAL CANAL, WHILE TRACTION WAS MAINTAINED ON THE PURSE STRING SUTURE. AROUND TWENTY SECONDS LATER, THE STAPLER WAS CLOSED AND FIRED. IN DGHAL GROUP, A 6-10 FIGURES OF EIGHT STITCHES WERE PERFORMED USING VICRYL 2/0 WITH A 5/8 CURVED NEEDLE THROUGH THE ANOSCOPE WINDOW. LIGATION OF THE VESSEL WAS CONFIRMED BY THE ABSENCE OF THE DOPPLER ARTERIAL SIGNAL DISTAL TO THE SUTURE LINE. POSTOPERATIVE COMPLICATIONS INCLUDED PAIN [N=80, (N=63 SH GROUP AND N=17 DGHAL GROUP)] WHICH ALL REQUIRED VARYING AMOUNTS OF ANALGESIA; AND HEMORRHOIDAL BLEEDING AND PROLAPSE [N=11, (N=2 IN SH GROUP AND N=9 IN DGHAL GROUPS)] WHICH ONE OF THE PATIENTS IN SH GROUP UNDERWENT CONVENTIONAL HEMORRHOIDECTOMY FOR CONTROL OF STAPLE LINE BLEEDING BY SUTURING, WHILE THE OTHER IN SH GROUP REFUSED ADDITIONAL TREATMENT. FIVE OF THESE PATIENTS IN DGHAL GROUP WERE REOPERATED, ONE UNDERWENT RUBBER BAND LIGATION, WHILE THE OTHER THREE PATIENTS REFUSED ADDITIONAL TREATMENTS. BOTH SH AND DGHAL ARE SAFE AND EFFECTIVE METHODS FOR TREATING GRADE III HEMORRHOIDS. EACH OF THEM MAY BE CONSIDERED AS A SUITABLE ALTERNATIVE TO CONVENTIONAL HEMORRHOIDECTOMY WITH NO RISK OF POSTOPERATIVE STOOL INCONTINENCE, MINIMAL POSTOPERATIVE PAIN, AND A HIGH PATIENT SATISFACTION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497197 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention