BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTASEAL DUAL APPLICATOR

    MDR report key: 14718151 · Received June 16, 2022

    Report

    Report Number
    2210968-2022-04613
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Report Date
    July 19, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    MZM
    UDI-DI
    10705031462533
    PMA / PMN Number
    BK180287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: IS THE USER A NEW USER TO VISTASEAL? IF NOT, HOW MANY TIMES HAVE THEY USED VISTASEAL PRIOR TO THIS EVENT? IT WAS NOT THE USERS FIRST TIME. HE HAS USED IT 2 TIMES PRIOR. THEN 3 OTHER PEOPLE TRIED THE OTHER BEFORE THEY COULD GET ONE ACTUALLY WORK. HOW MANY TIMES HAVE THEY APPLIED THE LAPAROSCOPIC TIP? IT WAS NOT THE USERS FIRST TIME. HE HAS USED IT 2 TIMES PRIOR. THEN 3 OTHER PEOPLE TRIED THE OTHER BEFORE THEY COULD GET ONE ACTUALLY WORK. WAS A SALES REPRESENTATIVE PRESENT DURING THE CASE WHEN THE ISSUE WAS EXPERIENCED? THERE WAS NO SALES REP PRESENT WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? THE FIRST ONE HAD PRODUCT IN THE LUER LOCK SO I'M NOT SURE IF THAT WAS DEFECTIVE TO BEGIN WITH BUT THE OTHERS HAD NO VISIBLE PRODUCTS. ALL STOCKED PRODUCT WOULD HAVE EXPIRED THE NEXT DAY OR SO SO I AM NOT SURE IF THAT HAS ANYTHING TO DO WITH IT. 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. WHAT IS THE LOT NUMBER OF EACH DAMAGED DEVICE? WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? ARE THERE PICTURES OF THE DAMAGED DEVICES AVAILABLE? IS A SAMPLE AVAILABLE TO BE RETURNED FOR EVALUATION? IF SO, PLEASE PROVIDE THE CURRENT STATUS OF THE SAMPLE AND AVAILABLE TRACKING INFORMATION. EVENT RELATED TO MW # 2210968-2022-04611, MW # 2210968-2022-04612, MW # 2210968-2022-04614. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THEY WERE UNABLE TO REMOVE THE GREY LUER LOCKS IN ORDER TO APPLY THE LAPAROSCOPIC TIP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1857290 VISTASEAL DUAL APPLICATOR FIBRIN SEALANT PREPARATION DEVICE MZM ETHICON INC. VSTAS1 10705031462533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown