BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS VIO 8X70CM M2 USP3/0 SGLE ARMED SH C/R

    MDR report key: 22717114 · Received August 5, 2025

    Report

    Report Number
    2210968-2025-09073
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    June 23, 2025
    Report Date
    August 5, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K181652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 8/5/2025. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: - WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE(S)? - WERE THERE PATIENT CONSEQUENCES? IF YES, PLEASE EXPLAIN. --RECEIVED INFORMATION AS FOLLOWING FROM SALES REP VIA PHONE TODAY. PLEASE REFER TO THE EVENT DESCRIPTION, OTHER INFORMATION REQUESTED IS UNKNOWN. THE MISSING NEEDLE TIP IN THIS EVENT WAS NOT FOUND FINALLY. THIS EVENT DID NOT CAUSE ANY OTHER HARM TO THE PATIENT EXCEPT FOR PROLONGED OPERATION TIME (SPECIFIC EXTENSION TIME WAS UNKNOWN). THE PATIENT HAS BEEN DISCHARGED SMOOTHLY NOW. NO SUBSEQUENT ADVERSE EVENTS WERE REPORTED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. D4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC RADICAL RESECTION OF SIGMOID COLON CANCER, LAPAROSCOPIC UNILATERAL SALPINGO OOPHORECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED FOR TREATMENT DUE TO INTERMITTENT RECTAL BLEEDING FOR SIX MONTHS. ON THE 8TH DAY OF ADMISSION, SURGERY WAS PERFORMED, AND THE DOCTOR USED SUTURE. DURING THE SURGERY, THE MAIN SURGEON RETRACTED THE STAPLER NEEDLE AND FOUND A MISSING NEEDLE TIP (1ML) WHEN PUTTING IT BACK ON THE NEEDLE PLATE. AFTER MULTIPLE EFFORTS, THE MISSING NEEDLE TIP WAS NOT FOUND. AFTER THE SURGERY, NO MISSING NEEDLE TIP WAS FOUND THROUGH X-RAY FLUOROSCOPY LAPAROSCOPY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2498277 VICRYL PLUS VIO 8X70CM M2 USP3/0 SGLE ARMED SH C/R SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. S24070041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown