BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8813361 · Received July 22, 2019

    Report

    Report Number
    3005075853-2019-20624
    Event Type
    Injury
    Date Received
    July 22, 2019
    Report Date
    June 28, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2016. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: HIGH-GRADE HEMORRHOIDS REQUIRING SURGICAL TREATMENT ARE COMMON AFTER LAPAROSCOPIC VENTRAL MESH RECTOPEXY. AUTHORS: J. J. VAN IERSEL, H. A. FORMIJNE JONKER, P. M. VERHEIJEN, W. A. DRAAISMA, E. C. J. CONSTEN, I. A. M. J. BROEDERS. CITATION: TECH COLOPROCTOL (2016); 20:235¿242. DOI: 10.1007/S10151-016-1432-8. THE AIM OF THIS STUDY WAS TO IDENTIFY PATIENTS DEVELOPING HIGHGRADE HEMORRHOIDS REQUIRING SURGICAL TREATMENT AFTER LAPAROSCOPIC VENTRAL MESH RECTOPEXY (LVMR) AND TO EXPLORE THE RELATIONSHIP BETWEEN SUCH HEMORRHOIDS AND THE RECURRENCE OF RECTAL PROLAPSE FOLLOWING LVMR. SIXTY FIVE PATIENTS (4 MALE AND 61 FEMALE) DEVELOPED SYMPTOMATIC GRADE III/IV HEMORRHOIDS WHICH REQUIRED EITHER STAPLED HEMORRHOIDECTOMY (SH) OR EXCISIONAL HEMORRHOIDECTOMY (TEH) AFTER UNDERGOING LVMR. IN SH GROUP, 63 PATIENTS UNDERWENT SH USING PPH 03 (ETHICON), AND IN TEH GROUP, 2 PATIENT UNDERWENT TRADITIONAL EXCISIONAL HEMORRHOIDECTOMY. REPORTED COMPLICATIONS IN THE SH GROUP INCLUDED RECURRENT GRADE III/ IV HEMORRHOIDS (N-?) WHICH NEEDED A RE-DO SURGERY, EXTERNAL RECTAL PROLAPSE (ERP) RECURRENCE (N-?) IN WHICH PATIENTS UNDERWENT RE-DO LVMR, INTERNAL RECTAL PROLAPSE (IRP) RECURRENCE (N-?) IN WHICH PATIENTS RE-DO RECTOPEXY AND ONE PATIENT REQUIRED RE-DO OF SH 9 MONTHS AFTER THE RE-DO RECTOPEXY, AND PERSISTENT FECAL INCONTINENCE (N-3) IN WHICH A STOMA WAS CREATED. IN CONCLUSION, HIGH-GRADE HEMORRHOIDS REQUIRING SURGERY MAY BE COMMON AFTER LVMR. THE DEVELOPMENT OF HIGHGRADE HEMORRHOIDS AFTER LVMR MIGHT BE CONSIDERED A PREDICTOR OF RECTAL PROLAPSE RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605007 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention