BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL CT BRD VIO 36IN 1 S/A CT

    MDR report key: 8727744 · Received June 24, 2019

    Report

    Report Number
    2210968-2019-83179
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031039278
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. ATTEMPTS HAVE BEEN 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT TISSUE WAS THE NEEDLE USED ON DURING THE HERNIA PROCEDURE 15 MAY? THE POSSIBLE SITE IN WHICH THE NEEDLE-SUTURE WAS USED IS FASCIA. WAS THERE ANY DEFICIENCY OR ANOMALY NOTED WITH THE NEEDLE BEFORE OR DURING USE? NO FURTHER INFORMATION IS AVAILABLE. WHAT WAS THE SIZE OF THE BROKEN NEEDLE TIP (IN CM)? ABOUT 3MM IN (B)(6) INVESTIGATION. WAS THE BROKEN NEEDLE /NEEDLE PIECES REMOVED FROM THE PATIENT? YES. WHAT IS THE CURRENT RATIONAL FOR THE PATIENT HOSPITALIZATION? THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6). WHAT IS THE SURGEON¿S OPINION OF THE HOSPITALIZATION AND THE SUTURE NEEDLE BREAKAGE? THE SURGEON COMMENTED THAT IT CANNOT BE SAID ANYTHING SINCE WHETHER THE NEEDLE-SUTURE IS THE CAUSE IS UNKNOWN. WHAT IS THE CURRENT CONDITION OF THE PATIENT? THERE IS NO PROBLEM IN PARTICULAR. THE PATIENT WAS DISCHARGED ON (B)(6). DO YOU HAVE THE NEEDLE FOR EVALUATION? TRACKING NUMBER? WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A WF HERNIOTOMY ON (B)(6) 2019 AND SUTURE WAS USED. THE POSSIBLE SITE IN WHICH THE NEEDLE-SUTURE WAS USED IS FASCIA. DURING THE PROCEDURE, THE NEEDLE BROKE. FOLLOWING THE PROCEDURE, THERE WAS A POSSIBILITY THAT THE BROKEN NEEDLE TIP HAD BEEN LEFT IN THE PATIENT¿S BODY. IN POST-OPERATIVE MRI DONE ON (B)(6) 2019, HALATION THAT SEEMED DUE TO REMAINING OF METAL IN THE PATIENT¿S BODY OCCURRED. ON (B)(6) 2019, THE PATIENT UNDERWENT REOPERATION UNDER GENERAL ANESTHESIA AND THE METAL WAS RETRIEVED FROM A LAYER BELOW THE FASCIA. THE INCISION SIZE FOR THE REOPERATION WAS ABOUT 5CM. THE REMAINED METAL WAS CONSIDERED AS A SUTURE NEEDLE BY THE APPEARANCE AND THE REMAINING SITE. THE HOSPITALIZATION PERIOD WAS EXTENDED BY ONE WEEK. THE PATIENT WAS DISCHARGED ON (B)(6) 2019 WITH NO PROBLEMS. NO ADDITIONAL TREATMENT IS PLANNED. THERE IS A POSSIBILITY THAT THE REMAINED NEEDLE TIP WAS ANOTHER COMPANY¿S NEEDLE (ELP NEEDLE-SUTURE (SUTURE SIZE 4)) WHICH WAS ALSO USED IN THE OPERATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520428 VCL CT BRD VIO 36IN 1 S/A CT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. MJZ378 10705031039278

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention