BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24299636 · Received February 9, 2026

    Report

    Report Number
    2210968-2026-01461
    Event Type
    Injury
    Date Received
    February 9, 2026
    Date of Event
    January 1, 2025
    Report Date
    February 9, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: ARCH GYNECOL OBSTET. 2025 AUG;312(2):555-561. HTTPS://DOI.ORG/10.1007/S00404-025-08040-4 EPUB 2025 MAY 6. PMID: 40327066; PMCID: PMC12334526.

    Description of Event or Problem · 0

    TITLE: TOTALLY INTRACORPOREAL COLORECTAL ANASTOMOSIS (TICA) AFTER SEGMENTAL COLORECTAL RESECTION FOR DEEP ENDOMETRIOSIS: TECHNICAL NOTES AND CASE SERIES. THE AIM OF THIS STUDY WAS TO EVALUATE THE SAFETY AND FEASIBILITY OF TOTALLY INTRACORPOREAL COLORECTAL ANASTOMOSIS (TICA) IN PATIENTS UNDERGOING COLORECTAL RESECTION FOR THE TREATMENT OF DEEP ENDOMETRIOSIS (DE) AFFECTING THE BOWEL. BETWEEN JANUARY 2021 AND AUGUST 2024, 33 CONSECUTIVE PATIENTS WITH DE TREATED WITH SEGMENTAL COLORECTAL RESECTION WERE ENROLLED. ECHELON FLEX (EES) AND ENDOPATH STAPLERS (EES) WERE USED TO CARRRIED OUT UNTIL REACHING THE RECTAL WALL BELOW THE ENDOMETRIOTIC NODULE, AND THEN THE RECTUM WAS TRANSECTED WITH A LINEAR STAPLER. VICRYL (ETH) WAS USED TO BOUND AT THE HOLE OF THE TIP. REPORTED COMPLICATION: 0 VICRYL (ETH) POSTOPERATIVE BLEEDING OF THE ANASTOMOSIS (N=2) TREATMENT: NOT REPORTED POSTOPERATIVE ILEUS (N=1) TREATMENT: MEDICALLY TREATED IN CONCLUSIONS, THE STUDY SHOWS THAT TICA IS A SAFE AND FEASIBLE TECHNIQUE IN PATIENTS WHO UNDERGO LAPAROSCOPIC COLORECTAL RESECTION FOR DE. FURTHER STUDIES ARE STILL REQUIRED TO EVALUATE A POSSIBLE IMPROVEMENT IN FUNCTIONAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355943 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other