BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 21576954 · Received March 11, 2025

    Report

    Report Number
    3005075853-2025-01919
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    January 1, 2022
    Report Date
    March 11, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/11/2025. 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. 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: TITLE: A PROSPECTIVE AND COMPARATIVE STUDY OF SHORT TERM RESULTS OF OPEN HEMORRHOIDECTOMY VERSUS STAPLED HEMORRHOIDOPEXY AUTHORS: DR. REEGAN JOSE.M1, DR. NIVEDHA.R2, DR. SRINIDHI.K3 CITATION:JOURNAL OF PHARMACEUTICAL NEGATIVE RESULTS/ DOI: 10.47750/PNR.2022.13.S09.825. THE AIM OF PROSPECTIVE AND COMPARATIVE STUDY WAS TO COMPARE THE SHORT TERM RESULTS OF STAPLED HEMORRHOIDOPEXY(SH) WITH OPEN HEMORRHOIDECTOMY(OH) WITH RESPECT TO OPERATING TIME, POST-OPERATIVE PAIN AND IMMEDIATE POST-OPERATIVE COMPLICATIONS. BETWEEN JUNE 2014 TO AUGUST 2015, A TOTAL OF NINETY PATIENTS (57 MALE AND 33 FEMALE WITH MEAN AGE OF 21->60 YEARS OLD) UNDERGOING SURGERY FOR HEMORRHOIDS AT SRM MEDICAL COLLEGE, KATTANKULATHUR ,WHO FULFILLED THE CRITERIA WERE INCLUDED IN THE STUDY. FORTY FIVE PATIENTS UNDERWENT MILLIGAN MORGAN TECHNIQUE OF OPEN HEMORRHOIDECTOMY AND FORTY FIVE PATIENTS UNDERWENT LONGO TECHNIQUE OF STAPLED HEMORRHOIDOPEXY. THE STAPLED PROCEDURE WAS PERFORMED ACCORDING TO THE TECHNIQUE DESCRIBED BY LONGO. A 33-MM CIRCULAR STAPLING DEVICE PART OF PPH03 KIT (PROXIMATE; ETHICON ENDOSURGERY, CINCINNATTI, OHIO, USA) WAS USED .THE PPH03 KIT INCLUDES ALL OF THE REQUIRED COMPONENTS OF THE PROCEDURE, EXCEPT FOR A SUTURE. THIS ANOSCOPE IS A SEMICIRCULAR INSTRUMENT THAT FACILITATES THE PLACEMENT OF THE PURSE STRING SUTURE. A PURSE ¿ STRING SUTURE OF 2/0 POLYPROPYLENE WAS INSERTED AT LEAST 4CM ABOVE THE DENTATE LINE, CATCHING ONLY THE MUCOSA AND SUBMUCOSA. REPORTED COMPLICATIONS INCLUDE : RETENTION (N=7) TREATMENT: NOT PROVIDED. BLEEDING (N=5) TREATMENT: NOT PROVIDED. PAIN (N=13) TREATMENT: NOT PROVIDED. IN SUMMARY, THE FINDINGS TO THE STUDY CONFIRM THAT STAPLED HEMORRHOIDOPEXY IS ASSOCIATED WITH SHORTER DURATION OF SURGERY, LESS POSTOPERATIVE PAIN AND NEED FOR ANALGESIA, WITH MINIMAL POST-OPERATIVE COMPLICATIONS AS COMPARED WITH MILLIGAN ¿ MORGAN (OPEN )HEMORRHOIDECTOMY. THERE IS NO RECURRENCE, RESIDUAL PROLAPSE OR INCONTINENCE IN THE FOLLOW UP PERIOD OF SIX MONTHS . STAPLED HEMORRHOIDOPEXY IS SAFE WITH MANY SHORT- TERM BENEFITS. IT IS A NOVEL TECHNIQUE AND HAS EMERGED AS AN ALTERNATIVE TO OPEN HEMORRHOIDECTOMY , LONG CONSIDERED THE ¿GOLD STANDARD¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334312 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention