BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 16112978 · Received January 6, 2023

    Report

    Report Number
    2210968-2023-00136
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    August 29, 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. 1. PLEASE CLARIFY HOW THE PRODUCT WAS DEFECTIVE 2. ANY PATIENT CONSEQUENCES? 3. WHAT IS THE PATIENT¿S CURRENT HEALTH STATUS AND CONDITION? H3 ANALYSIS SUMMARY: (B)(4) TEAM RECEIVED FOR EVALUATION A TVTO DEVICE (PRODUCT CODE 810081), BATCH 3941740. THE PRODUCT WAS DECONTAMINATED AND WELL PACKAGED. THE RECEIVED DEVICE WAS MANIPULATED, AS ORIGINAL PACKAGING AND SEVERAL COMPONENTS WERE MISSING (BOX, IFU, BLISTER, AND ONE NEEDLE, THE ATRAUMATIC WINGED GUIDE). WERE RETURNED ONLY: THE LID WITH IDENTIFICATION LABEL, 2 TROCARS, 1 NEEDLE ATTACHED WITH BLUE MESH AND 1 PLASTIC SHEATH, THE OTHER PLASTIC SHEATH WAS FREE FROM THE ASSEMBLY. IT CAN BE OBSERVED THAT ORGANIC MATTER IS VISIBLE OVER THE RETURNED THE TROCARS AND PLASTIC SHEATH AND BLUE MESH. THE NEEDLE RETURNED HAS THE TIP DAMAGED, THE BLUE MESH IS WRINKLED AND FRAYED IN SEVERAL PARTS, THE PLASTIC SHEATH ATTACHED TO THE NEEDLE IS ALSO DAMAGED. THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION COULD NOT BE OBSERVED DURING THE PRODUCT EVALUATION, THE OTHER NEEDLE IS MISSING FROM THE ASSEMBLY AND NO DEFECT WAS OBSERVED ON BOTH TROCARS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE DEFECT IDENTIFIED IS NOT LINKED TO A MANUFACTURING ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6)2022 AND MESH WAS USED. DISABLE TO TUNNELING AND TROCAR MALFUNCTION WERE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484508 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810081 3941740 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1 Female