BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 17072700 · Received June 6, 2023

    Report

    Report Number
    3005075853-2023-03829
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    June 21, 2022
    Report Date
    June 24, 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
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/6/2023. D4: BATCH # UNK. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/24/2025. INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: AUTHORS: PO-CHUNG LIN, MIN-HSUAN YEN2 KEE-THAI KIU, YU-CHUN YEN, KA-WAI TAM, TUNG-CHENG CHANG. CITATION CITE: LANGENBECK'S ARCHIVES OF SURGERY (2022) 407:3005¿3012. HTTPS://DOI.ORG/10.1007/S00423-022-02587-5. THIS STUDY AIMS TO EVALUATE THE BENEFIT AND SAFETY OF PEP IN HEMORRHOIDAL SURGERY. IN THIS STUDY, WE USED DATA FROM PATIENTS TREATED AT (B)(6) HOSPITAL BETWEEN (B)(6) 2020 AND (B)(6) 2021. DATA OF 270 CONSECUTIVE PATIENTS, WITH 130 AND 140 IN THE PEP AND NON-PEP GROUPS, RESPECTIVELY, WHO UNDERWENT HEMORRHOIDAL SURGERY WERE ANALYZED. IN HEMORRHOIDOPEXY, A PPH03(PROXIMATE® PPH CIRCULAR STAPLER) STAPLER IS USED. REPORTED COMPLICATIONS INCLUDES: INFECTION (N-1), URINARY RETENTION (N-4), DELAYED BLEEDING (N-4), PAIN (N-?). CONCLUSION: FINDINGS REVEALED THAT PERFORMING PEP BEFORE HEMORRHOIDAL SURGERY PRODUCED NO BENEFIT WHEN COMPARED WITH NOT PERFORMING PEP. TYPICALLY, THE PROCEDURE OF PEP IS INCONVENIENT AND DISCOMFORTING FOR PATIENTS. THEREFORE, WE SUGGEST THAT IT CAN BE OMITTED IN HEMORRHOIDAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735935 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PPH03 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention