BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 12379705 · Received August 27, 2021

    Report

    Report Number
    3005075853-2021-05050
    Event Type
    Injury
    Date Received
    August 27, 2021
    Date of Event
    January 6, 2021
    Report Date
    August 6, 2021
    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 · 1

    (B)(4). BATCH # UNKNOWN. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: MODIFIED PROCEDURE FOR PROLAPSE AND HEMORRHOIDS: LOWER RECURRENCE, HIGHER SATISFACTION, AUTHORS: YAN-YU CHEN, YI-FAN CHENG, QUAN-PENG WANG, BO YE, CHONG-JIE HUANG, CHONG-JUN ZHOU, MAO CAI, YUN-KUI YE, CHANG-BAO LIU, CITATION: WORLD J CLIN CASES (2021); 9(1): 36-46. DOI: HTTPS://DX.DOI.ORG/10.12998/WJCC.V9.I1.36. THE AIM OF THIS RETROSPECTIVE COHORT STUDY IS TO COMPARE THE THERAPEUTIC EFFECTS AND THE PATIENTS¿ SATISFACTION AFTER M-PPH, PPH AND MMH. BETWEEN JANUARY 2012 TO DECEMBER 2014, A TOTAL OF 1163 PATIENTS WHO UNDERWENT SURGERY FOR GRADE III/IV HEMORRHOID PROLAPSE WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE GROUP ACCORDING TO THE TREATMENT PERFORMED: 381 PATIENTS (190 MALE AND 191 FEMALE; MEDIAN AGE OF 46 (17-84) YEARS) IN MILLIGAN-MORGAN HEMORRHOIDECTOMY (MMH GROUP), 321 PATIENTS (153 MALE AND 168 FEMALE; MEDIAN AGE OF 46 (18-87) YEARS) IN THE TRADITIONAL PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH GROUP), AND 461 PATIENTS (261 MALE AND 200 FEMALE; MEDIAN AGE OF 46 (17-86) YEARS) IN THE MODIFIED PPH (M-PPH GROUP). A PPH03 HEMORRHOIDAL CIRCULAR STAPLER (ETHICON) WAS USED FOR BOTH THE ORIGINAL PPH AND M-PPH PROCEDURES. THE MEAN FOLLOW-UP PERIOD WAS 5 ± 0.5 (RANGE: 4¿6) YEARS. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE ANASTOMOTIC BLEEDING (N=7%), IN 5 PATIENTS, WHO FAILED TO RESPOND TO CONSERVATIVE TREATMENT, WHO REPEATEDLY EXPERIENCED ANASTOMOTIC BLEEDING AFTER M-PPH WERE TREATED WITH AN 8-SHAPE SUTURE IN AN OUTPATIENT OPERATION, AFTER WHICH BLEEDING CEASED; SENSATION OF RECTAL TENESMUS (N=25%); POSTOPERATIVE RECURRENCE (N=27.5%) IN WHICH 15 PATIENTS AND 13 PATIENTS WITH RECURRENT SYMPTOMATIC THIRD-DEGREE HEMORRHOIDS IN THE PPH GROUP AND M-PPH GROUP RESPECTIVELY UNDERWENT MM SURGERY, WHILE THE 45 PATIENTS AND 27 PATIENTS WITH RECURRENT SECOND-DEGREE HEMORRHOIDS IN THE PPH GROUP AND M-PPH GROUP RESPECTIVELY WERE TREATED WITH SCLEROTHERAPY. NONE OF THESE PATIENTS EXPERIENCED ANY FURTHER RECURRENCES DURING THE FOLLOW-UP PERIOD; ANAL DISCHARGE (N=11.8%) AND ANAL INCONTINENCE (N=6.2%) WHICH IMPROVED AFTER 6 MONTHS FOLLOW-UP; ANAL STENOSIS (N=6.1%); POORLY SATISFIED (N=135); DISSATISFIED (N=64). IN CONCLUSION, THIS STUDY FOUND THAT, WITHIN THE FOLLOW-UP PERIOD OF 5 YEARS, M-PPH HAS MANY ADVANTAGES, INCLUDING A LOWER RECURRENCE RATE AND A HIGHER PATIENT SATISFACTION RATE THAN CONVENTIONAL PPH. NEVERTHELESS, M-PPH IS ASSOCIATED WITH HIGHER RATES OF SENSATION OF RECTAL TENESMUS AND OF ANAL INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275395 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PPH03 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1