BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 23723079 · Received December 4, 2025

    Report

    Report Number
    2210968-2025-13630
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    March 20, 2025
    Report Date
    December 4, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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. 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 SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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 NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (B)(4) IS NOT AVAILABLE. CITATION: WORLD J SURG ONCOL. 2025 MAR 20;23(1):97. HTTPS://DOI.ORG/10.1186/S12957-025-03737-X. PMID: 40114143; PMCID: PMC11924735.

    Description of Event or Problem · 0

    TITLE: SAFETY AND EFFICACY OF PANCREATICOGASTROSTOMY FOR HEPATOPANCREATODUODENECTOMY COMPARED TO PANCREATICOJEJUNOSTOMY FOR PERIHILAR CHOLANGIOCARCINOMA. THE AIM OF THIS MULTI-CENTER RETROSPECTIVE STUDY WAS TO INVESTIGATE AND COMPARE THE SHORT-TERM OUTCOMES OF PANCREATICOGASTROSTOMY (PG) AND PANCREATICOJEJUNOSTOMY (PJ) FOR HEPATOPANCREATODUODENECTOMY (HPD) IN TERMS OF THE POSTOPERATIVE PANCREATIC FISTULA (POPF) RATE. BETWEEN JANUARY 2013 AND JANUARY 2024, A TOTAL OF 50 PATIENTS (13 WERE FEMALES; MEAN AGE WAS 74 (50¿82) YEARS) WHO UNDERWENT HPD FOR PERIHILAR CHOLANGIOCARCINOMA WERE INCLUDED IN THE STUDY. THE PG AND PJ GROUPS COMPRISED 15 (30.0%) AND 35 (70.0%) PATIENTS, RESPECTIVELY. IN THE PG RECONSTRUCTION, A 4-0 POLYDIOXANONE SUTURES (PDS II, ETHICON) WAS USED TO SUTURE THE PANCREATIC PARENCHYMA AND THE STOMACH INTO A WHOLE LAYER. AFTER CLOSING THE ANTERIOR WALL OF THE STOMACH VIA LAYER-TO-LAYER ANASTOMOSIS USING 4-0 PDF, THE FIRST 3-0 MONOFILAMENT POLYPROPYLENE THREAD WAS SUTURED TO THE POSTERIOR STOMACH WALL AND FIXED. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE BILE LEAKAGE (N=2) AND POSTOPERATIVE ARTERY BLEEDING (N=1). IN CONCLUSION, CHANGING THE METHOD OF PANCREATIC RECONSTRUCTION FROM PJ TO PG FOR HPD IMPROVED THE SHORT-TERM OUTCOMES IN OUR INSTITUTION. PG RECONSTRUCTION IS SAFE AND EFFECTIVE FOR HPD IN REDUCING THE INCIDENCE OF CR-POPF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438680 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention