BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTASEAL DUAL APPLICATOR

    MDR report key: 14488518 · Received May 24, 2022

    Report

    Report Number
    2210968-2022-04023
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Date of Event
    January 1, 2022
    Report Date
    May 24, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    MZM
    UDI-DI
    10705031462533
    PMA / PMN Number
    BK180287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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? THE TECHNICIAN THAT WAS PREPARING THE VISTASEAL IS NOT NEW TO THIS PRODUCT. THE SURGEON THAT SHE WAS WITH HAS USED MANY TIMES. HOW MANY TIMES HAVE THEY APPLIED THE LAPAROSCOPIC TIP? NUMEROUS TIMES. WAS A SALES REPRESENTATIVE PRESENT DURING THE CASE WHEN THE ISSUE WAS EXPERIENCED? NO. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? NO. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? NO. PLEASE PROVIDE LOT NUMBER. NOT AVAILABLE. THE SURGICAL TECHNICIAN SAID THAT SHE WAS ABLE TO GET THE PRODUCT WORKING AS IT SHOULD. THE LUERS WERE DIFFICULT TO TURN, HOWEVER, SHE ADMITTED THAT SHE MAY HAVE BEEN TURNING THE LUER LOCKS IN THE WRONG DIRECTION. THE TECH INFORMED THAT THEY WERE ABLE TO REMOVE THE OPEN TIP TO REPLACE WITH THE LAPAROSCOPIC TIP AND THE DEVICE WAS USED FOR THE PROCEDURE AND DISCARDED. THERE IS NO DEVICE AVAILABLE FOR RETURN. 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. THE SURGICAL TECHNICIAN COULD NOT GET THE OPEN TIP OFF OF THE FIBRIN SEALANT PREPARATION DEVICE IN ORDER TO APPLY A LAP APPLICATOR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488410 VISTASEAL DUAL APPLICATOR FIBRIN SEALANT PREPARATION DEVICE MZM ETHICON INC. VSTAS1 10705031462533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown