BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8817617 · Received July 23, 2019

    Report

    Report Number
    3005075853-2019-20671
    Event Type
    Injury
    Date Received
    July 23, 2019
    Report Date
    June 26, 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
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2010 . 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: DISAPPOINTING LONG-TERM OUTCOMES AFTER STAPLED TRANSANAL RECTAL RESECTION FOR OBSTRUCTED DEFECATION.AUTHOR: KHALED M. MADBOULY, KHALED S. ABBAS, AHMED M. HUSSEIN.CITATION: WORLD J SURG. 2010; 34: 2191¿2196. DOI: 10.1007/S00268-010-0638-6.THE AIM OF THIS STUDY WAS TO ASSESS BOTH SHORT AND LONG-TERM FUNCTIONAL OUTCOMES AND THE QUALITY OF LIFE OF PATIENTS TREATED WITH STAPLED TRANSANAL RECTAL RESECTION (STARR) FOR OBSTRUCTED DEFECATION SYNDROME (ODS). A TOTAL OF 46 PATIENTS (16 MALE AND 30 FEMALE PATIENTS; AGE RANGE: 29 TO 68 YEARS OLD) WITH ODS AS A RESULT OF RECTOCELE AND/OR RECTAL INTUSSUSCEPTIONS WERE TREATED WITH STARR AND WERE INCLUDED IN THE STUDY. THE STARR PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA WITH THE PATIENT IN THE LITHOTOMY POSITION USING PPH-01 (ETHICON). VICRYL 3-0 STITCHES (ETHICON) WERE USED TO CONTROL BLEEDING FROM THE SUTURE LINE IN 42 PATIENTS. REPORTED COMPLICATIONS INCLUDED MINIMAL POST-OPERATIVE PAIN (N-45), SEVERE PAIN IN WHICH THE DENTATE WAS PARTIALLY ENTANGLED IN THE STAPLE LINE (N-1), STENOSIS AT THE STAPLE LINE (N-3) WHICH RESPONDED TO MANUAL DILATATION, RECURRENT MARKED OBSTRUCTED DEFECATION WITH A SENSE OF INCOMPLETE RECTAL EVACUATION (N-14) WHICH NEEDED THE USE OF LAXATIVES, ENEMAS, OR SELF-DIGITATION TO EVACUATE, RECTOCELE TYPE II (N-3), RECTAL INTUSSUSCEPTION (N-3), AND TEMPORARY FLATUS INCONTINENCE (N-5). STARR IS A SAFE SURGICAL PROCEDURE THAT EFFECTIVELY RESTORES ANATOMY AND FUNCTION OF THE ANORECTUM IN PATIENTS WITH ODS. THE PROCEDURE IMPROVES FUNCTIONAL AND QOL SCORES; HOWEVER, A PROGRESSIVE HIGH RATE OF SYMPTOMATIC RECURRENCE AND A DECLINE IN THE QOL SCORE ARE EXPECTED WITH TIME. PREOPERATIVE DIGITATION, PARITY, AND LONG FOLLOW-UP ARE RISK FACTORS FOR SYMPTOM RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608758 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention