BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8704236 · Received June 17, 2019

    Report

    Report Number
    3005075853-2019-19804
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    January 1, 2004
    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

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2004. 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: SEVERE INTRA-ABDOMINAL BLEEDING FOLLOWING STAPLED MUCOSECTOMY DUE TO ENTEROCELE: REPORT OF A CASE AUTHORS: G. AUMANN, S. PETERSEN, T. POLLACK, G. HELLMICH, K. LUDWIG CITATION: TECH COLOPROCTOL (2004); 8:41¿43. DOI 10.1007/S10151-004-0050-Z. THE AUTHORS REPORTED A CASE OF A PATIENT WHO EXPERIENCED INTRAABDOMINAL BLEEDING FOLLOWING STAPLED RECTAL MUCOSECTOMY (SRM). A (B)(6)-YEAR-OLD MALE PATIENT, WITH THREE-QUADRANT THIRD-DEGREE PILES, WAS ADMITTED FOR HAEMORRHOIDECTOMY. THE PATIENT UNDERWENT STAPLED RECTAL MUCOSECTOMY USING THE 33-MM PROXIMATE HCS (PPH 01) HAEMORRHOIDAL CIRCULAR STAPLER (ETHICON). REPORTED COMPLICATIONS INCLUDED ACTIVE BLEEDING FROM THE RECTUM IN THE ABDOMINAL CAVITY CAUSING SEVERE ABDOMINAL PAIN AND SYMPTOMS OF PERITONITIS, AND LONGITUDINAL DEFECT OF THE ANTERIOR ASPECT OF THE RECTUM IN WHICH THE SEROSA DEFECT WAS SUTURED AND A DIVERTING SIGMOID STOMA WAS CARRIED OUT. NO COMPLICATIONS WERE SEEN POST OPERATIVELY AND THE PATIENT LEFT THE HOSPITAL 10 DAYS LATER. IN CONCLUSION, THE AUTHORS EMPHASIZE VIGILANCE FOR UNDETECTED ENTEROCELES IN MUCOSAL PROLAPSE SYNDROME COMBINED WITH DEFECATION PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497154 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention