BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8723599 · Received June 21, 2019

    Report

    Report Number
    3005075853-2019-19960
    Event Type
    Injury
    Date Received
    June 21, 2019
    Report Date
    May 30, 2019
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: COMPLICATIONS AND REOPERATIONS IN STAPLED ANOPEXY: LEARNING BY DOING. AUTHOR(S): JOHANNES JONGEN; JENS-UWE BOCK; HANS-GÜNTER PELEIKIS; ANNE EBERSTEIN; KARIN PFISTER. CITATION: INT J COLORECTAL DIS (2006) 21: 166¿171 / DOI: 10.1007/S00384-005-0784-8. THE PURPOSE OF THIS PROSPECTIVE STUDY WAS TO ANALYZE THE LONGTERM OUTCOME OF STAPLED ANOPEXY USING A DATABASE OF 654 PATIENTS TO ASSESS PATIENT SELECTION CRITERIA, COMPLICATIONS, AND THE NEED FOR REINTERVENTIONS FOR ANORECTAL PATHOLOGY. FROM 1998 TO AUG 2003, A TOTAL OF 654 PATIENTS [N=296 FEMALE, N=358 MALE, MEAN AGE 51.5 YEARS (RANGE 19 TO 84)] WITH SECOND AND THIRD DEGREE HEMORRHOIDS WHO UNDERWENT STAPLED ANOPEXY. THE PATIENTS WERE DIVIDED INTO THREE GROUPS DEPENDING IN THE DEVICE USED: SDH GROUP (N=129), PPH01 GROUP (N=467) AND EEA-31 GROUP (N=58). IN PPH01 GROUP, PPH01 DEVICE WAS USED TO PERFORM THE PROCEDURE. POSTOPERATIVE COMPLICATIONS INCLUDED FECAL RETENTION (N=18) TWO REQUIRED REOPERATION; BLEEDING (N=25) 23 REQUIRED REOPERATION; ANASTOMOTIC DEHISCENCE (N=21) ALL REQUIRED REOPERATION; PERSISTENCE OF PROLAPSE (N=3); SUBMUCOSAL ANASTOMOTIC CYSTS (N=4) TWO REQUIRED REOPERATION; THROMBOSED EXTERNAL HEMORRHOID (N=6) FIVE REQUIRED REOPERATION; ANAL SKIN TAGS (N=10) SEVEN REQUIRED REOPERATION; ANAL FISSURE (N=10) ALL REQUIRED REOPERATION; FECAL INCONTINENCE (N=10); STENOSIS (N=3) TWO REQUIRED REOPERATION; ANAL ITCHING (N=7) ALL REQUIRED REOPERATION; REPOLARISE (N=8) ALL REQUIRED REOPERATION; AND PAPILLA (N=6) ALL REQUIRED REOPERATION. STAPLED ANOPEXY IS A SAFE PROCEDURE FOR TREATING HEMORRHOIDAL DISEASE WITH APPROPRIATE PATIENT SELECTION AND TRAINING OF THE SURGICAL TEAM. ADDITIONAL ANORECTAL PROCEDURES MAY BE SAFELY PERFORMED, AND ALTHOUGH PATIENTS MAY HAVE MORE POSTOPERATIVE PAIN, THEY MAY AVOID A DELAYED PROCEDURE FOR ANAL TAGGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517095 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1