BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8855961 · Received August 2, 2019

    Report

    Report Number
    3005075853-2019-20929
    Event Type
    Injury
    Date Received
    August 2, 2019
    Date of Event
    January 1, 2009
    Report Date
    July 10, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2009. 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: NEW APPROACH TO LARGE HAEMORRHOIDAL PROLAPSE: DOUBLE STAPLED HAEMORRHOIDOPEXY. AUTHORS: GABRIELE NALDINI, JACOPO MARTELLUCCI, PASQUALE TALENTO, ANGELO CAVIGLIA, LUCA MORALDI, MAURO ROSSI. CITATION: INT J COLORECTAL DIS (2009); 24:1383¿1387. DOI: 10.1007/S00384-009-0750-Y. THE AIMS OF THIS STUDY WERE TO VERIFY IF IN LARGE HAEMORRHOIDAL PROLAPSES (INDEPENDENT FROM DEGREE) IN PATIENTS WITH NO SYMPTOMS OF OBSTRUCTED DEFAECATION SYNDROME (ODS), THE USE OF A STAPLED HAEMORRHOIDOPEXY VARIANT, COMPRISING A DOUBLE STAPLER HAEMORRHOIDOPEXY (DSH), MAKES IT POSSIBLE TO REDUCE THE PERCENTAGE OF FAILURES OR RELAPSES; AND TO STANDARDISE AN OBJECTIVE INTRAOPERATIVE PARAMETER FOR THE PURPOSE OF QUANTIFYING INTERNAL PROLAPSES WHICH CAN THEN BE USED AS A GUIDE IN DETERMINING THE TYPE OF TREATMENT TO BE PROVIDED. BETWEEN JUNE 2003 AND JUNE 2004, 353 PATIENTS (97 MALE AND 256 FEMALE; MEAN AGE: 47; AGE RANGE: 20-76) WERE OPERATED IN THREE CENTRES FOR HAEMORRHOIDAL PROLAPSE. THE OCCUPATION OF MORE THAN HALF OF THE LENGTH OF THE CIRCULAR ANAL DILATOR (CAD) OF A SET PPH 01 (ETHICON) BY PROLAPSE DURING THE EVALUATION UNDER ANAESTHESIA WAS TAKEN AS AN OBJECTIVE PARAMETER FOR ESTABLISHING THE EXTENT OF THE PROLAPSE AND THE INDICATION TO DSH. EIGHTY-THREE PATIENTS UNDERWENT DSH (DSH GROUP) AND 270 PATIENTS UNDERWENT STAPLED ANOPEXY (SA GROUP). REPORTED COMPLICATIONS IN THE DSH GROUP INCLUDED RESIDUAL ILLNESSES/RESIDUAL DISEASE/RESIDUAL PROLAPSE (N-3), RELAPSE ILLNESS/ RELAPSED PROLAPSE/RECURRENCE OF PROLAPSE (N-5), URGENCY AT <3 MONTHS (N-6), POSTOPERATIVE BLEEDING WITH NECESSITY OF HAEMOSTASIS REVISION (N-2) AND, RECTAL HAEMATOMA SPONTANEOUSLY DRAINED (N-1). IN THE SH GROUP, REPORTED COMPLICATIONS INCLUDED RESIDUAL ILLNESS/RESIDUAL PROLAPSE (N-9), RELAPSED ILLNESS/RECURRENCE OF PROLAPSE (N-12), URGENCY AT <3 MONTHS (N-18), POSTOPERATIVE BLEEDING WITH NECESSITY OF HAEMOSTASIS REVISIONS (N-7), AND RECTAL HAEMATOMA SPONTANEOUSLY DRAINED (N-2). IN CONCLUSION, THE INTRAOPERATIVE SELECTION CRITERION WAS BOTH EFFICACIOUS AND REPRODUCIBLE. THIS VARIANT TECHNIQUE, WHICH CAN BE USED IN LARGE HAEMORRHOIDAL PROLAPSES, COULD ALLOW FOR FURTHER IMPROVEMENT IN THE QUALITY OF TREATMENT FOR HAEMORRHOIDAL CONDITIONS USING STAPLED HAEMORRHOIDOPEXY, WITHOUT INCREASING THE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652123 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention