BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTASEAL LAPAROSCOPIC DUAL APPLICATOR F

    MDR report key: 11809323 · Received May 11, 2021

    Report

    Report Number
    2210968-2021-04453
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 6, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    MZM
    UDI-DI
    10705031462724
    PMA / PMN Number
    BK190324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/14/2021. 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, 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 · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 5/25/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. WHAT IS THE LOT NUMBER? THE LOT # IS 5114464. 2. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? NO, THERE WAS A SLIGHT DELAY AS THE SURGEON FOUND AND REMOVED THE BROKEN O-RING, BUT NO IMPACT TO THE PATIENT NOR THE VISTASEAL PRODUCT¿S EFFICACY. 3. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? NO PICTURES. 4. IS THE DEVICE AVAILABLE TO BE RETURNED FOR EVALUATION? IF SO, PLEASE PROVIDE THE STATUS OF THE RETURN AND ANY AVAILABLE TRACKING INFORMATION. YES. 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, 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 · 0

    PRODUCT COMPLAINT # ==> (B)(4) DATE SENT TO THE FDA: 7/15/2021 INVESTIGATION SUMMARY ==> ONE VSTL45 WAS RETURNED, ATTACHED TO A VST10 DEVICE. NO WHITE SPRAY TIPS WERE RETURNED. THE O-RING WAS RETURNED, AND IT WAS SPLIT OPEN ON ONE SIDE. THERE WERE SIGNS OF WEAR AT THE THREADED CONNECTOR INDICATING THAT A DEVICE WAS USED TO STEER THE END OF THE TIP IN THE AREA WHERE THE O-RING SITS. HOWEVER, IT IS UNKNOWN WHAT ACTUALLY CAUSED THE O-RING TO BREAK OFF. THERE ARE NO OTHER SIGNS OF DAMAGE TO THE O-RING ASIDE FROM THE AREA THAT SPLIT. 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, 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. CORRECTED INFORMATION: D7A, D9, H3, H6

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 5/28/2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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, 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

    PRODUCT COMPLAINT # (B)(4). ATTEMPTS HAVE BEEN 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. 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. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? IS THE DEVICE AVAILABLE TO BE RETURNED FOR EVALUATION? IF SO, PLEASE PROVIDE THE STATUS OF THE RETURN AND ANY AVAILABLE TRACKING INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2021 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED AFTER TUMOR REMOVAL DURING DEFECT CLOSURE. THE WHITE SPRAY TIP WAS REMOVED PRIOR TO USE SO THE PRODUCT COULD BE DRIPPED IN MULTIPLE LOCATIONS. AFTER BEING MOVED TO USE THE LAST AMOUNT OF PRODUCT ON THE HILUM OF THE KIDNEY, IT WAS NOTICED THAT THE ORANGE RUBBER O-RING HAD BROKEN OFF. IT WAS QUICKLY GRABBED AND REMOVED ALONG WITH THE EMPTY DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THREE-MINUTE DELAY. THE BROKEN O-RING WAS REMOVED SUCCESSFULLY WITHOUT THE NEED OF ADDITIONAL INTERVENTION. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704990 VISTASEAL LAPAROSCOPIC DUAL APPLICATOR F FIBRIN SEALANT PREPARATION DEVICE MZM ETHICON INC. VSTL45 5114464 10705031462724

    Patients

    Seq Age Sex Outcome Treatment
    1