BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24318833 · Received February 11, 2026

    Report

    Report Number
    2210968-2026-01567
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    October 10, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J CLIN MED. 2025 OCT 10;14(20):7133. DOI: 10.3390/JCM14207133. PMID: 41156003; PMCID: PMC12565143. HTTPS://DOI.ORG/10.3390/JCM14207133.

    Description of Event or Problem · 0

    RENAL FUNCTIONAL OUTCOMES IN ROBOT-ASSISTED PARTIAL NEPHRECTOMY WITH MINIMUM LAYER RESECTION USING VIRTUAL THREE-DIMENSIONAL IMAGE ASSISTANCE. THE AIM OF THIS STUDY IS TO ANALYZE 237 PATIENTS (AFTER SCREENING 312 CASES) WHO UNDERWENT RAPN BETWEEN 2012 AND 2022 WITH =36-MONTHFOLLOW-UP. 3-0 VICRYL (ETH) WAS USED TO INDIVIDUALLY LIGATED AS REQUIRED, AND SLIDING-CLIP STITCHES IN BLOOD VESSELS. REPORTED COMPLICATIONS: 3-0 VICRYL (ETH) MLR GROUP (N=163) MAJOR COMPLICATION (CLAVIEN-DINDO CLASSIFICATION 4>) (N=2) TREATMENT: NOT REPORTED. POST-OP ACUTE KIDNEY INJURY (AKI) (N=32) TREATMENT: NOT REPORTED. LOCAL OR DISTANT RECURRENCE (N=6) TREATMENT: NOT REPORTED. NON MLR GROUP (N=74) MAJOR COMPLICATION (CLAVIEN-DINDO CLASSIFICATION 4>) (N=2) TREATMENT: NOT REPORTED. POST-OP ACUTE KIDNEY INJURY (AKI) (N=27) TREATMENT: NOT REPORTED. LOCAL OR DISTANT RECURRENCE (N=2) TREATMENT: NOT REPORTED. IN CONCLUSION, RAPN WITH THE MLR TECHNIQUE UNDER 3DVPN GUIDANCE DEMONSTRATED FAVORABLE PERIO PERATIVE OUTCOMES, ACCEPTABLE ONCOLOGIC SAFETY, AND GOOD MID-TERM RENAL FUNCTIONAL PRESERVATION (UP TO 36 MONTHS). THE APPROACH PROVIDES A REPRODUCIBLE SURGICAL STRATEGY THAT MAXIMIZES PARENCHYMAL PRESERVATION WHILE MAINTAINING NEGATIVE SURGICAL MARGINS. PROSPECTIVE MULTICENTER STUDIES WITH LONGER FOLLOW-UP ARE WARRANTED TO CONFIRM LONG-TERM DURABILITY AND TO DEFINE THE ROLE OF MLR IN ROUTINE PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373645 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other