BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 11081631 · Received December 28, 2020

    Report

    Report Number
    2210968-2020-10331
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    December 2, 2020
    Report Date
    December 7, 2020
    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). DATE SENT TO FDA: 02/02/2021. PHOTO ANALYSIS SUMMARY: A PICTURE WAS RECEIVED FOR EVALUATION. UPON VISUAL INSPECTION OF THE IMAGE, THE WHITE COVER OF THE TROCAR WAS PARTIALLY INSERTED OF PRODUCT CODE 810081, LOT 3937205 COULD BE OBSERVED. NO CONCLUSION COULD BE REACHED AS ON WHAT CAUSED THE REPORTED COMPLAINT, SINCE THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 3/5/2021.   H3 EVALUATION: THE DEVICE WAS RECEIVED AND EVALUATED BY THE MANUFACTURER. THE RECEIVED DEVICE WAS MANIPULATED AS THERE WAS NO PACKAGING (NO LID NOR BLISTER). A PART OF THE BOX WAS SENT WITH BATCH NUMBER AND BAR CODES. THE HELICAL PASSERS WERE INSERTED IN THE WHITE PLASTIC NEEDLES CORRECTLY. THE TIP OF ONE NEEDLE WAS TWISTED AND DAMAGED. THE MESH WAS STILL ASSEMBLED TO THE NEEDLES. THE WINGED GUIDE WAS ALSO PRESENT. THE DEFECT ON DEVICE SEEN DURING THE PRODUCT EVALUATION IS ALIGNED WITH THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION. THE IDENTIFIED DEFECT IS NOT LINKED TO A MANUFACTURING ISSUE. EVENTS OF THIS TYPE ARE TRENDED REGULARLY, THEREFORE THIS COMPLAINT IS BEING CLOSED TO TRENDING. 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, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGICAL PROCEDURE ON (B)(6) 2020 AND MESH WAS USED. IT WAS REPORTED THAT THE WHITE COVER OF THE TROCAR WAS NOT ADHERED TO, SO THE TROCAR COULD NOT BE INSERTED PROPERLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548104 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810081 3937205 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1