BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 16419200 · Received February 22, 2023

    Report

    Report Number
    2210968-2023-01311
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    November 28, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031000346
    PMA / PMN Number
    K033568
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. - WHAT QUALITY ISSUE WAS EXPERIENCED WITH THE PRODUCT? - IS THE QUALITY ISSUE SPECIFIC TO THE DEVICE OR PATIENT CONSEQUENCE? - WAS THERE ANY PATIENT CONSEQUENCE? ANALYSIS SUMMARY: NEUCHÂTEL TEAM RECEIVED FOR EVALUATION A PRODUCT TVTO DEVICE (PRODUCT CODE 810081), BATCH 3941740. THE PRODUCT WAS DECONTAMINATED AND WELL PACKAGED. THE RECEIVED DEVICE WAS MANIPULATED, AS PARTS OF THE ORIGINAL PACKAGING WERE MISSING (BOX, BLISTER). EVALUATION OF RECEIVED DEVICE: -A LID WAS RECEIVED WITH THE LOT LABEL: 3941740 -WINGED GUIDE: NO DAMAGES WERE DETECTED DURING THE EVALUATION -HANDLES: NO DAMAGES WERE DETECTED DURING THE EVALUATION. -THE TWO PLASTIC NEEDLES/ TROCARS: IT WAS OBSERVED BOTH NEEDLE TIPS WERE RECEIVED DAMAGED BENDED. ONE NEEDLE WAS FOUND ALSO PARTIALLY BROKEN. -BLUE MESH: IT WAS OBSERVED THAT SOME STITCHES WERE BROKEN ON THE EDGES OF THE MESH , THE MESH HAS BEEN EXTENDED, AS THE PLASTIC SHEATH ARE NO LONGER OVERLAPPED. THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION ("TROCAR MALFUNCTION, TUNNELING FAILURE"), IS ALIGNED WITH THE DEFECTS SEEN ON THE DEVICE DURING THE PRODUCT EVALUATION, AS BOTH TROCARS/ NEEDLES TIPS WERE BENDED, ALSO ONE NEEDLE WAS OBSERVED PARTIALLY BROKEN, HOWEVER, THE DEFECTS IDENTIFIED DURING THE PRODUCT EVALUATION ARE NOT LINKED TO A MANUFACTURING ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGICAL PROCEDURE ON (B)(6) 2022 AND MESH WAS USED. AN UNSPECIFIED TROCAR MALFUNCTION AND TUNNELING FAILURE OCCURRED. ANOTHER DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319304 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810081 3941740 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown