BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8812317 · Received July 22, 2019

    Report

    Report Number
    3005075853-2019-20599
    Event Type
    Injury
    Date Received
    July 22, 2019
    Report Date
    June 26, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2012. 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: TITLE: PARTIAL STAPLED HEMORRHOIDOPEXY VERSUS CIRCULAR STAPLED HEMORRHOIDOPEXY FOR GRADE III¿IV PROLAPSING HEMORRHOIDS: A TWO-YEAR PROSPECTIVE CONTROLLED STUDY. AUTHOR/S: H.-C. LIN, D.-L. REN, Q.-L. HE, H. PENG, S.-K. XIE, D. SU, X.-X. WANG. CITATION: TECH COLOPROCTOL. 2012; 16: 337¿343. DOI: 10.1007/S10151-012-0815-8. CIRCULAR STAPLED HEMORRHOIDOPEXY (CSH) IS AN EFFECTIVE TECHNIQUE FOR TREATING PROLAPSING HEMORRHOIDS; BUT URGENCY AND ANAL STENOSIS ARE COMMON POSTOPERATIVE COMPLICATIONS. THE AIM OF THIS STUDY WAS TO ASSESS THE EFFICACY AND POSTOPERATIVE OUTCOMES OF PARTIAL STAPLED HEMORRHOIDOPEXY (PSH), COMPARED WITH CSH. SEVENTY-TWO CONSECUTIVE PATIENTS WITH GRADE III AND IV HEMORRHOIDS WHO MET THE INCLUSION/EXCLUSION CRITERIA WERE DIVIDED IN A NON-RANDOMIZED MANNER TO UNDERGO EITHER PSH (34 PATIENTS; AGE RANGE: 25 TO 68 YEARS OLD; 23 MALE AND 11 FEMALE PATIENTS) OR CSH (38 PATIENTS; AGE RANGE: 25 TO 76 YEARS OLD; 25 MALE AND 13 FEMALE PATIENTS). DURING THE SURGICAL PROCEDURE IN THE CSH GROUP, PPH-03 KIT (ETHICON) WAS USED. DURING THE SURGICAL PROCEDURE IN THE PSH GROUP, A VICRYL 2-0 PURSE-STRING SUTURE (ETHICON) WAS PLACED APPROXIMATELY 3 CM ABOVE THE DENTATE LINE, AND THE NEEDLE ONLY CAUGHT THE MUCOSA AND/OR SUBMUCOSA THAT PROTRUDED THROUGH THE WINDOW. REPORTED COMPLICATIONS IN THE PSH GROUP INCLUDED INTRAOPERATIVE BLEEDING OF THE STAPLE LINE (N-28) IN WHICH HEMOSTATIC SUTURES WERE PLACED, VAS FOR PAIN (N-13.5), FECAL URGENCY (N-27), POST-OPERATIVE HEMORRHAGE (N-2) AND WERE SUCCESSFULLY STOPPED BY PRESSURE WITH GAUZE OR LOCAL ADRENALINE ENEMA WITHOUT ANY SUBSEQUENT OPERATION, AND RECURRENT PROLAPSING HEMORRHOIDS (N-1). REPORTED COMPLICATIONS IN THE CSH GROUP INCLUDED VAS FOR PAIN (N-15), FECAL URGENCY (N-65), POST-OPERATIVE HEMORRHAGE (N-2) AND WERE SUCCESSFULLY STOPPED BY PRESSURE WITH GAUZE OR LOCAL ADRENALINE ENEMA WITHOUT ANY SUBSEQUENT OPERATION, ANAL STENOSIS (N-1) WHICH REQUIRED MANUAL ANAL DILATATION, AND RECURRENT PROLAPSING HEMORRHOIDS (N-2). THE PRESENT STUDY DEMONSTRATES THAT PSH (THREE-POINT SUSPENSION) ACHIEVED THE SAME EFFECT AS CSH (CIRCULAR SUSPENSION) DID IN THE MANAGEMENT OF PROLAPSING HEMORRHOIDS. THE 2-YEAR RECURRENCE RATE AFTER PSH AND CSH FOR GRADE III¿IV PROLAPSING HEMORRHOIDS IS SIMILAR. HOWEVER, PSH IS ASSOCIATED WITH LESS POSTOPERATIVE PAIN, FEWER EPISODES OF URGENCY, AND NO POSTOPERATIVE ANAL INCONTINENCE OR ANAL STENOSIS. THEREFORE, BASED ON OUR EXPERIENCE, PSH APPEARS TO BE A MINIMALLY INVASIVE TECHNIQUE IN THE TREATMENT OF GRADE III¿IV PROLAPSING HEMORRHOIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605711 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1