BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ VIO 8X27IN 3-0 S/A SH CR

    MDR report key: 18679686 · Received February 9, 2024

    Report

    Report Number
    2210968-2024-01222
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    January 5, 2024
    Report Date
    March 14, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031055551
    PMA / PMN Number
    K032420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: RECEIVED INFORMATION AS FOLLOWING FROM SALES REP VIA PHONE TODAY. AFTER INVESTIGATION, THE PATIENT WAS A 49-YEAR-OLD MALE WHO UNDERWENT LAPAROSCOPIC REPAIR OF DUODENAL ULCER PERFORATION IN HOSPITAL ON (B)(6) 2024. THE SURGEON USED VCP784D FOR SEWING THE PERFORATION SITE IN A CONTINUOUS SUTURING MANNER DURING THE SURGERY, AND PULL OFF SUTURE NEEDLE OCCURRED DURING SEWING. THE SURGEON IMMEDIATELY LOOKED FOR THE DETACHED NEEDLE. THE NEEDLE WAS FOUND AND REMOVED UNDER DIRECT VISION. THE INTEGRITY OF THE NEEDLE WAS CHECKED AFTER REMOVAL. AFTER CONFIRMING THAT THERE WAS NO RESIDUAL FOREIGN BODY IN THE PATIENT, A NEW SUTURE WAS REPLACED (SPECIFIC PRODUCT INFORMATION WAS UNKNOWN) FOR SEWING. THE SUBSEQUENT SURGERY WENT SMOOTHLY. THIS EVENT DID NOT CAUSE ANY OTHER HARM TO THE PATIENT EXCEPT FOR PROLONGED OPERATION TIME (SPECIFIC PROLONGATION TIME WAS UNKNOWN), AND NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4) 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. 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: 1. WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? CONTACTED WITH THE SALES REP TODAY VIA PHONE, PLEASE REFER TO THE EVENT DESCRIPTION AND OTHER INFORMATION REQUESTED IS UNKNOWN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC REPAIR OF DUODENAL ULCER PERFORATION UNDER GENERAL ANESTHESIA PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 15:20, THE DOCTOR SUTURED THE PERFORATION SITE WITH SUTURE DURING SURGERY. WHEN PULLING THE NEEDLE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE ABDOMINAL CAVITY, AND THEN THE NEEDLE WAS REMOVED UNDER DIRECT ENDOSCOPY. THIS EVENT CAUSED AN EXTENSION OF THE SURGICAL TIME AND INCREASED THE RISK OF UNCLEAR ITEM COUNTING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378644 VCL+ VIO 8X27IN 3-0 S/A SH CR SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. TCMHQH 10705031055551

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male