BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 21525006 · Received March 5, 2025

    Report

    Report Number
    3005075853-2025-01777
    Event Type
    Injury
    Date Received
    March 5, 2025
    Date of Event
    May 15, 2024
    Report Date
    March 5, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/5/2025 D4: BATCH # UNK D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: THEN LEAVE ED AS IS. TITLE: RANDOMIZED CONTROLLED TRIAL TO COMPARE STAPLED HEMORRHOIDOPEXY PLUS LIGATION ANOPEXY WITH STAPLED HEMORRHOIDOPEXY FOR MANAGING GRADE III AND IV HEMORRHOIDAL DISEASE AUTHORS: WALID GALAL ELSHAZLY, M.D. ¿ MOHMED ABDELHALIM ABO ELROS, F.R.C.S. AMR SAMIR ALI, F.R.C.S. ¿ AHMED MOHAMED RADWAN, F.R.C.S. CITATION: DIS COLON RECTUM 2024; 67: 812¿819 DOI: 10.1097/DCR.0000000000003273. . THE PURPOSE OF THIS RANDOMIZED CONTROLLED STUDY WAS TO COMPARE THE SHORT-TERM AND LONG-TERM OUTCOMES OF STAPLED HEMORRHOIDOPEXY (SH) ALONE VERSUS STAPLED HEMORRHOIDOPEXY PLUS LIGATION ANOPEXY (SH + LA), FOCUSING ON RECURRENCE, PATIENT SATISFACTION, PAIN, COMPLICATIONS, AND QUALITY OF LIFE AFTER SURGERY. BETWEEN JANUARY 2018 AND (B)(6) 2020, A TOTAL OF 124 PATIENTS WITH GRADE III AND IV HEMORRHOIDS. THE MEAN AGE WAS 43.1± 11.6 IN GROUP I, AND 43.7± 10.8 IN GROUP II. MOST PATIENTS WERE WOMEN 33 IN GROUP I AND 32 IN GROUP II. MOST PATIENTS HAD GRADE III HEMORRHOIDAL DISEASE 39 IN GROUP I AND 40 IN GROUP II. THE SURGERY PERFORMED WAS STAPLED HEMORRHOIDOPEXY (SH) IN GROUP I AND STAPLED HEMORRHOIDOPEXY PLUS LIGATION ANOPEXY (SH + LA) IN GROUP II. BOTH GROUPS HAD 62 PATIENTS EACH. IN THE GROUP OF PATIENTS UNDERGOING SH WITH LA, THE PURSESTRING SUTURE ANOSCOPE (PSA33), WHICH COMES WITH THE SH SET (ETHICON ENDO-SURGERY, CINCINNATI, OH), OR SIM¿S SPECULUM WAS USED BY THE OPERATOR AFTER SH WAS COMPLETED. TO FIX THE MUCOSA AND SUBMUCOSA TO THE UNDERLYING INTERNAL SPHINCTER, A HALF-CIRCLE (SIZE 26) NEEDLE WITH 2-0 POLYGLACTIN (VICRYL, ETHICON ENDO-SURGERY, OH) WAS INSERTED 2 CM ABOVE THE DENTATE LINE, ALMOST AT THE STAPLE LINE OF SHSH WAS PERFORMED ACCORDING TO THE TECHNIQUE DESCRIBED BY GIORDANO ET AL13 USING A 2/0 POLYPROPYLENE PURSE STRING SUTURE TO THE MUCOSA AND SUBMUCOSA, 4 CM ABOVE THE DENTATE LINE. FOR THE MUCOSECTOMY AND ANOPEXY, A SPECIALIZED CIRCULAR STAPLING DEVICE (PPH03; ETHICON ENDO-SURGERY, CINCINNATI, OH) THE MEAN FOLLOW-UP PERIOD WAS 36 MONTHS (RANGE 24¿47 MONTHS). REPORTED COMPLICATIONS INCLUDED RECTAL BLEEDING (N=?), URINARY RETENTION (N=?), DYSURIA (N=?), FECAL URGENCY (N=?), HEMATOMA (N=?). IN CONCLUSION, SH COMPARED TO SH PLUS LA WERE SIMILAR IN SHORT-TERM RESULTS WITH REGARD TO COMPLICATIONS RATE, HEMORRHOIDS SYMPTOMS SCORE, RETURN TO WORK, AND QUALITY OF LIFE. MEAN 3-YEAR FOLLOW-UP RESULTS WERE SIGNIFICANTLY BETTER REGARDING THE RECURRENCE OF EXTERNAL SWELLING AND/OR PROLAPSE AND PATIENT SATISFACTION AFTER SH PLUS LA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2275900 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention