BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 23705535 · Received December 3, 2025

    Report

    Report Number
    2210968-2025-13527
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    September 27, 2024
    Report Date
    December 3, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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 (01) GTIN IS NOT AVAILABLE. CITATION: FORMOSAN JOURNAL OF SURGERY (2025) 58:1 DOI:HTTP://DX.DOI.ORG/10.1097/FS9.0000000000000182.

    Description of Event or Problem · 0

    TITLE: INTRACORPOREAL ANASTOMOSIS VERSUS EXTRACORPOREAL ANASTOMOSIS FOLLOWING LAPAROSCOPIC RIGHT HEMICOLECTOMY: SURGICAL OUTCOMES OF A SINGLE-CENTER OBSERVATIONAL STUDY. THE AIM OF THIS STUDY IS TO COMPARE ICA (INTRACORPOREAL ANASTOMOSIS) WITH ECA (EXTRACORPOREAL ANASTOMOSIS) REGARDING SURGICAL OUTCOMES IN OUR TERTIARY CARE HOSPITAL. FROM JANUARY 2021 TO JANUARY 2022,A TOTAL OF 138 PATIENTS WERE INCLUDED AND DIVIDED INTO TWO GROUPS. THERE WERE INTRACORPOREAL ANASTOMOSIS GROUP (N = 71) WITH THE MEAN AGE OF 52 PLUS OR MINUS 9.8 YEARS OLD, 40 MALES AND 31 FEMALES AND EXTRACORPOREAL ANASTOMOSIS GROUP (N = 67) WITH THE MEAN AGE OF 54.2 PLUS OR MINUS 8.7 YEARS OLD WITH 35 MALES AND 32 FEMALES ALL PATIENTS WITH BENIGN AND MALIGNANT CONDITIONS FOR ELECTIVE RIGHT HEMICOLECTOMY. PATIENTS WHO HAD COMBINED RESECTION OF OTHER ORGANS, TRAUMA PATIENTS UNDERGOING LAPAROTOMY, AND STOMA PATIENTS WERE EXCLUDED. INTRACORPOREAL ANASTOMOSIS USING LAPAROSCOPIC STAPLER, THE TERMINAL ILEUM AND TRANSVERSE COLON WERE TRANSECTED USING AN ENDO-GIA STAPLER (BLUE CARTILAGE; ETHICON, CINCINNATI CITY, OH). THEN, A SIDE-TO-SIDE ISOPERISTALTIC ILEOCOLIC ANASTOMOSIS WAS DONE. THE INCISION WAS CLOSED WITH CONTINUOUS PDS (POLYDIOXANONE) 2-0 SUTURES. THE SPECIMEN IS EXTRACTED THROUGH PFANNENSTIEL INCISION. EXTRACORPOREAL ANASTOMOSIS A PFANNENSTIEL INCISION IS MADE TO EXTERIORIZE THE TERMINAL ILEUM, RIGHT COLON, AND PROXIMAL TRANSVERSE COLON FOLLOWED BY STAPLED GIA STAPLER (BLUE CARTILAGE; ETHICON) ISOPERISTALTIC ILEOCOLIC ANASTOMOSIS. THE INCISION WAS CLOSED WITH CONTINUOUS PDS 2-0 SUTURES. POSTOPERATIVE FOLLOW-UP WAS PERFORMED AT THE SURGICAL CLINIC DURING EARLY 30 DAYS POSTOPERATIVELY. REPORTED COMPLICATIONS: PDS (POLYDIOXANONE) 2-0 SUTURES (ETHICON): (N=4) PATIENTS HAD SURGICAL SITE INFECTION IN INTRACORPOREAL ANASTOMOSIS GROUP TREATMENT: NOT REPORTED. (N=6) PATIENTS HAD SURGICAL SITE INFECTION IN EXTRACORPOREAL ANASTOMOSIS GROUP TREATMENT: NOT REPORTED. (N=1) PATIENT HAD ANASTOMOTIC BLEEDING IN INTRACORPOREAL ANASTOMOSIS GROUP TREATMENT: WERE MANAGED CONSERVATIVELY. (N=2) PATIENTS HAD ANASTOMOTIC BLEEDING EXTRACORPOREAL ANASTOMOSIS GROUP. TREATMENT: WERE MANAGED CONSERVATIVELY. (N=2) PATIENTS HAD ANASTOMOTIC LEAK IN INTRACORPOREAL ANASTOMOSIS GROUP. TREATMENT: WERE MANAGED CONSERVATIVELY, AS WELL AS PERCUTANEOUS RADIOLOGICAL INTERVENTION WHEN NEEDED. (N=3) PATIENTS HAD ANASTOMOTIC LEAK IN EXTRACORPOREAL ANASTOMOSIS GROUP. TREATMENT: WERE MANAGED CONSERVATIVELY, AS WELL AS PERCUTANEOUS RADIOLOGICAL INTERVENTION WHEN NEEDED. IN CONCLUSION, ICA (INTRACORPOREAL ANASTOMOSIS) OFFERS COMPARABLE POSTOPERATIVE COMPLICATIONS TO ECA (EXTRACORPOREAL ANASTOMOSIS) BUT HAS ENHANCED PATIENT OUTCOMES IN TERMS OF RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857599 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention