BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 15412169 · Received September 13, 2022

    Report

    Report Number
    2210968-2022-07458
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    June 13, 2022
    Report Date
    November 18, 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
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. UPDATED PHOTO ANALYSIS SUMMARY: UPDATE ON THE FOLLOWING PHOTO EVALUATION MADE BY NEUCHÂTEL SITE: NEUCHÂTEL TEAM RECEIVED FOR EVALUATION ONE PHOTO OF TVTO DEVICE (PRODUCT CODE 810081), BATCH 3940325. IT CAN BE OBSERVED IN PHOTO THAT THE DEVICE WAS OPENED AND MANIPULATED AS THERE WAS NO BOX AND NO BLISTER. IN THE PHOTO ONE NEEDLE AND PART OF TROCAR AND IFU ARE PRESENT. IT CAN BE ALSO OBSERVED IN THE PHOTO THAT THE NEEDLE TIP IS BROKEN. ADDITIONALLY, ORGANIC MATTER CAN BE SEEN ON THE NEEDLE AND IN THE TROCAR. THE DEFECT SEEN DURING THE PHOTO EVALUATION IS ALIGNED WITH THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION, HOWEVER, THE DEFECT IDENTIFIED IS NOT LINKED TO A MANUFACTURING ISSUE. H3 ANALYSIS SUMMARY: NEUCHÂTEL TEAM RECEIVED FOR EVALUATION A PRODUCT TVTO DEVICE (PRODUCT CODE 810081), BATCH 3940325. THE PRODUCT WAS DECONTAMINATED AND WELL PACKAGED. THE RECEIVED DEVICE SHOW'S THAT ORIGINAL PACKAGING WAS MANIPULATED, BOTH BOX AND BLISTER WERE OPENED. IT WAS RETURNED: 1 BOX, 1 BLISTER WITH LID, 1 WORKSTATION, 2 TROCARS, 2 NEEDLES WITH THE MESH AND PLASTIC SHEATH STILL IN PLACE AND IFU'S ARE ALSO PRESENT. IT CAN BE OBSERVED THAT THE BATCH NUMBER ON THE BOX 3940325 (SAME LOT NUMBER DESCRIBED IN THE COMPLAINT FILE) DOES NOT MATCH THE BATCH NUMBER ON BLISTER LABELS AND LID (B)(6). IT CAN ALSO BE OBSERVED THAT ONE NEEDLE TIP IS BROKEN, THE OTHER HAS NO DAMAGE. ADDITIONALLY, ORGANIC MATTER IS PRESENT ON THE NEEDLE AND OVER THE 2 TROCAR'S. 1 NEEDLE IS DISASSEMBLED FROM ITS TROCAR, AND THE OTHER NEEDLE IS STILL ASSEMBLED ON THE SECOND TROCAR. THE DEFECT SEEN DURING THE PRODUCT EVALUATION, HOWEVER, THE DEFECT IDENTIFIED IS NOT LINKED TO A MANUFACTURING ISSUE. FURTHERMORE, NEUCHATEL TEAM COULD NOT CONFIRM WHICH LOT IS IMPACTED FOLLOWING THE DISCREPANCY OF LABELING OBSERVED DURING THE PRODUCT EVALUATION. EVENTS OF THIS TYPE ARE TRENDED REGULARLY, THEREFORE THIS COMPLAINT IS BEING CLOSED TO TRENDING. DURING THE PRODUCT EVALUATION, IT WAS DETECTED A LID WITH A LABEL FROM LOT 3939928. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOOD RELEASE CRITERIA FOR LOT 3939928 AND PRODUCT CODE 810081.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO FDA: 11/07/2022. 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. THE DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    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. PHOTO ANALYSIS SUMMARY: NEUCHÂTEL TEAM RECEIVED FOR EVALUATION ONE PHOTO OF TVTO DEVICE (PRODUCT CODE 810081), BATCH 3940325. IT CAN BE OBSERVED IN PHOTO THAT THE DEVICE WAS OPENED AND MANIPULATED AS THERE WAS NO BOX AND NO BLISTER. IN THE PHOTO ONE NEEDLE AND PART OF TROCAR AND IFU ARE PRESENT. IT CAN BE ALSO OBSERVED IN THE PHOTO THAT THE NEEDLE TIP IS BROKEN. ADDITIONALLY, ORGANIC MATTER CAN BE SEEN ON THE NEEDLE AND IN THE TROCAR. THE DEFECT SEEN DURING THE PHOTO EVALUATION IS ALIGNED WITH THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION, HOWEVER, 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. 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. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND A MESH DEVICE WAS USED. WHEN THE SURGEON USED THE SPIRAL INTRODUCER TO BREAK THROUGH THE CLOSED MEMBRANE, THE CANNULA BROKE. CHANGED A NEW PRODUCT TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2608353 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810081 3940325 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female