BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 16961915 · Received May 19, 2023

    Report

    Report Number
    2210968-2023-03700
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    February 28, 2023
    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. H3 ANALYSIS SUMMARY: NEUCHÂTEL TEAM RECEIVED FOR EVALUATION A PRODUCT TVTO DEVICE (PRODUCT CODE 810081), BATCH 3942365. THE PRODUCT WAS DECONTAMINATED AND WELL PACKAGED. THE RECEIVED DEVICE WAS MANIPULATED, THE ORIGINAL PACKAGING AND SOME DEVICE COMPONENTS WERE MISSING (BOX, BLISTER, LID, LABELS, WINGED GUIDE, PLASTIC SHEATH). EVALUATION OF RECEIVED DEVICE: HANDLES: NO DAMAGES WERE DETECTED DURING THE PRODUCT EVALUATION. THE TWO PLASTIC NEEDLES/ TROCARS: IT WAS OBSERVED ORGANIC MATTER INSIDE ONE NEEDLE, BOTH NEEDLES WERE RECEIVED CUTTED OFF FROM THE BLUE MESH, A PIECE OF THE BLUE MESH WITH THE PLASTIC SHEATH REMAINED ATTACHED TO THE EACH NEEDLES. IT WAS OBSERVED ON THE PARTS OF THE REMAINING BLUE MESH AND THE PLASTIC SHEATH ATTACHED TO THE EACH NEEDLE, THE STITCHES ON THE EDGES WERE BROKEN, AND THE PLASTIC SHEATH WAS WELL DAMAGED, SOME MESH KNITTING IS MAKING IS WAY OUT OF THE SHEATH. THE NEEDLES WERE FOUND DAMAGED ON THEIR SLOTS AND NEEDLE'S TIPS. THE BLUE MESH HAS BEEN RECEIVED CURLED, EXTENDED THE EDGES ROUGHLY DAMAGED. ALSO THE MESH KNITTING APPEARS SMALLER ON THE CURLED PART OF THE BLUE MESH. THE PLASTIC SHEATH WERE NO LONGER PRESENT. THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION IS ALIGNED WITH THE DEFECTS SEEN ON THE MESH DEVICE, DURING THE PRODUCT EVALUATION, HOWEVER, THE DEFECTS IDENTIFIED DURING THE PRODUCT EVALUATION ARE NOT LINKED TO A MANUFACTURING ISSUE. EVENTS OF THIS TYPE ARE TRENDED REGULARLY. 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 A SLING PROCEDURE ON (B)(6)2023 AND MESH WAS USED. PRE-OPERATIVELY, THERE WAS MESH TAPE DAMAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670607 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810081 3942365 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1 Female