BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 7724505 · Received July 26, 2018

    Report

    Report Number
    3005075853-2018-11592
    Event Type
    Injury
    Date Received
    July 26, 2018
    Date of Event
    January 1, 2007
    Report Date
    June 28, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036013003
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 7/26/20108; BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    TITLE: STAPLED ANOPEXY AND STARR IN SURGICAL TREATMENT OF HAEMORRHOIDAL DISEASE. AUTHOR : ITALO CORSALE , MARCO RIGUTINI, NICCOLO` FRANCIOLI , SONIA PANICUCCI, PIETRO ADRIANO MORI, FRANCESCO ALOISE. CITATION: UPDATES SURG. 2014; 66: 217¿222. DOI: 10.1007/S13304-014-0254-3. THE AUTHORS CARRIED OUT A RETROSPECTIVE INQUIRY OF THEIR EXPERIENCE IN THE SURGICAL TREATMENT OF THE HEMORRHOIDAL DISEASE, ANALYZING THE RESULTS OF THE 2 SURGICAL METHODS AND UNDERLINING THE FACTORS THAT ARE IN THEIR OPINION ESSENTIAL FOR A CORRECT THERAPEUTIC PLANNING. IN ORDER TO LIMIT THE INCIDENCE OF FAILURES, THE AUTHORS PROVIDED A REMOVAL TECHNIQUE OF GREATER AMOUNT OF PROLAPSED TISSUE THAT WAS CONSIDERED AN OPPORTUNITY TO USE THE STARR TECHNIQUE EVEN IN THE PRESENCE OF HEMORRHOIDAL DISEASE NOT BURDENED BY SYMPTOMS OF OBSTRUCTED DEFECATION. THE AUTHORS EVALUATED THE EARLY AND AT A DISTANCE RESULTS OF 285 PATIENTS WHO UNDERWENT SURGICAL RESECTION WITH TRANS-ANAL CIRCULAR STAPLER FOR SYMPTOMATIC III-IV DEGREE HEMORRHOIDS WITHOUT OBSTRUCTED DEFECATION DISORDERS. OF WHICH, 237 PATIENTS (94 MALE AND 143 FEMALE PATIENTS; AGE RANGE: 29 TO 71 YEARS OLD) WERE SUBJECTED TO STAPLED ANOPEXY PROCEDURE (SA), WHILE THE REMAINING 48 PATIENTS (27 MALE AND 21 FEMALE PATIENTS; AGE RANGE: 33 TO 71 YEARS OLD) UNDERWENT THE STAPLED TRANSANAL RECTAL RESECTION (STARR) PROCEDURE. IN THE SA GROUP, AN SA PROCEDURE WAS PERFORMED, 4 CM OVER THE LINEA DENTATA, A SUTURE SHAPED AS A TOBACCO BAG AND RESECTING THE PROLAPSE USING PPH-03 CIRCULAR STAPLER (ETHICON). IN THE STARR PROCEDURE, AS THE PROLAPSE OCCUPIED THE CIRCULAR ANAL DIVARICATOR (CAD) OVER THE HALF OF THE DEVICE, THE AUTHORS SUGGESTED TO CARRY OUT A STARR PROCEDURE PERFORMING TWO PARACHUTE SUTURES, ONE ON THE FRONT RECTAL WALL AND THE OTHER ONE ON THE REAR WALL, WITH 3 TRACTION STITCHES AND RESECTING THEM SEPARATELY BY MEANS OF 2 PPH-01 CIRCULAR STAPLERS (ETHICON) IN 13 CASES, OR 1 PPH-03 CIRCULAR STAPLER ON THE FRONT AND 1 PPH-01 CIRCULAR STAPLER ON THE REAR PART FOR 35 PATIENTS. IN BOTH GROUPS, HEMOSTASIS AT THE END OF OPERATION WAS GUARANTEED BY TRANSUTURAL STITCHES AND TRANS-ANAL TABOTAMP HEMOSTATIC PAD (ETHICON). IN THE SA GROUP, REPORTED COMPLICATIONS INCLUDED PERSISTENT RECTUM BLEEDING (N-7) WHICH REQUIRED RE-ADMISSION AND CONSERVATIVE THERAPY, RECTUM HEMATOMA (N-1), STENOSIS (N-6) WHICH WERE TREATED WITH CONSERVATIVE THERAPY, DEFECATION URGENCY (N-7), SYMPTOMATIC RECURRENCE (N-9), AND ASYMPTOMATIC RESIDUAL DISEASE (N-40). IN THE STARR GROUP, REPORTED COMPLICATIONS INCLUDED PERSISTENT RECTUM BLEEDING (N-2) WHICH REQUIRED HEMOSTASIS IN THE OPERATING ROOM (N-1) AND READMISSION AND CONSERVATIVE THERAPY (N-1), HEMATOMA OF THE POSTERIOR RECTUM (N-1) WHICH WAS INITIALLY TREATED CONSERVATIVELY AND LATER BY TRANS-ANAL SURGERY DUE TO PERSISTENT SENSATION OF OBSTACLE TO DEFECATION, STENOSIS (N-1) WHICH WAS FIRST TREATED WITH DILATATION WITH HEGAR PROBE AND THEN SURGICALLY THROUGH TRANSANAL SCAR EXCISION, CHRONIC ANAL PAIN (N-1) WHICH REQUIRED ADMINISTRATION OF ANALGESIC DRUGS, DEFECATION URGENCY (N-2) WHICH REQUIRED PELVIC BIOFEEDBACK (N-1), SYMPTOMATIC RECURRENCE (N-2), AND ASYMPTOMATIC RESIDUAL DISEASE (N-4). IT WAS REPORTED THAT THE SA TECHNIQUE OFFERS THE ADVANTAGE OF LESS POST-OPERATIVE PAIN, A QUICKER RECOVERY OF THE WORKING ACTIVITY, AND ALSO REPORTS A NON-RELEVANT OCCURRENCE OF POST-OPERATIVE BLEEDING AS COMPARED TO THE TRADITIONAL HEMORRHOIDECTOMY. IN THE CASE OF VOLUMINOUS PROLAPSES THAT APPEAR WITH THE HEMORRHOIDAL DISEASE ONLY, THE STARR PROCEDURE IS A SAFE TECHNIQUE AND CAN OPTIMIZE THE LONG LASTING EFFECTIVENESS OF THE TRANS-ANAL RESECTION SURGERY LIMITING THE INCIDENCE OF SYMPTOMATIC RELAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563416 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036013003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention