BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ VIO 27IN 2-0 S/A SH

    MDR report key: 23658396 · Received November 26, 2025

    Report

    Report Number
    2210968-2025-13297
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    August 7, 2025
    Report Date
    January 9, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031052253
    PMA / PMN Number
    K132580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. ADDITIONAL INFORMATION: H6, D9, H3. H3 INVESTIGATION SUMMARY: THE PRODUCT RECEIVED FOR ANALYSIS WAS VCP317H VISUAL INSPECTION AND METALLURGICAL ANALYSIS WERE PERFORMED ON THE RETURNED PRODUCT. A FAILED SUTURE NEEDLE, LABELED AS (B)(4) WAS SUBMITTED TO HERRERA, STAFFORD AND ASSOCIATES, LLC (HSA) FOR FRACTOGRAPHIC EVALUATION ON NOVEMBER 12, 2025. THE COMPONENT WAS IDENTIFIED AS PRODUCT CODE VCP317G. IT WAS REQUESTED THAT HSA ASSESS THE FRACTURE MODE OF THE FAILURE. A FRACTURE WAS OBSERVED NEAR THE TIP OF THE NEEDLE. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE EVALUATION OF (B)(4) REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE FRACTURE MODE. THIS WAS A DUCTILE FRACTURE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT LYMPH NODE BIOPSY SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE HOLDERS WERE RETURNED TO THE INSTRUMENTALIST WHEN THE SUBCUTANEOUS WAS CLOSED. THE INSTRUMENTALIST, WHEN CLEANING AND LOADING THE NEEDLE HOLDER ITSELF FOR THE SUBSEQUENT SKIN SUTURES, NOTICED THE PRESENCE OF THE NEEDLE TIP (PREVIOUSLY USED) BETWEEN THE NEEDLE HOLDER LEGS. USED ANOTHER DEVICE. NEEDLE BREAKAGE. NO PROBLEMS PER PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030341 VCL+ VIO 27IN 2-0 S/A SH SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. XBBDKRD0 10705031052253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown