BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD VIO 27IN 2-0 S/A SH

    MDR report key: 18758779 · Received February 22, 2024

    Report

    Report Number
    2210968-2024-01669
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Date of Event
    October 30, 2023
    Report Date
    February 22, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031038752
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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. 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. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: PRODUCT NAME: VCL CT BRD VIO 27IN 2-0 S/A SH, PRODUCT CODE: J317H, LOT NUMBER: UNK. PRODUCT NAME: VCL CT BRD VIO 27IN 2-0 S/A SH, PRODUCT CODE: J317H, LOT NUMBER: UNK. WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE? NO. IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE PIECE IN THE FUTURE? NO. IF YES, PLEASE PROVIDE THE SCHEDULED DATE. NA. WHAT TISSUE STRUCTURE THE BROKEN NEEDLE WAS LOCATED? WHAT IS THE SURGEON'S OPINION OF CONSEQUENCES TO THE PATIENT? NO RESPONSE FROM SURGEON PLEASE PROVIDE THE LOT NUMBER: UNKNOWN. PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: OR SUPERVISOR. EVENTS REPORTED VIA: (B)(4). USER FACILITY MEDWATCH FORM, #(B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SLEEVE GASTRECTOMY, LYSIS OF ADHESIONS; ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO ETHICON NEEDLES FROM A COATED VICRYL® (POLYGLACTIN 910) SUTURE PACKAGE BROKE OFF IN SITE WHILE SUTURING. THE BROKEN FRAGMENTS WERE UNABLE TO BE RETRIEVED. PER POLICY, NO X-RAY WAS REQUIRED DUE TO SIZE OF SUTURING NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66954 VCL CT BRD VIO 27IN 2-0 S/A SH SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. 10705031038752

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female