BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTASEAL LAPAROSCOPIC DUAL APPLICATOR R

    MDR report key: 13981871 · Received April 1, 2022

    Report

    Report Number
    2210968-2022-02330
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 16, 2022
    Report Date
    July 21, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    MZM
    UDI-DI
    10705031462571
    PMA / PMN Number
    BK190324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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) H3 INVESTIGATION SUMMARY ==>ACCORDING TO THE INFORMATION RECEIVED THE VSTL35 DEVICE, CONNECTION ISSUE (DEVICE). THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE VST04 DEVICE WAS RETURNED INSIDE PACKAGING OPENED. THE SYRINGE HOLDER WITH PRE-FILLED SYRINGE, ONLY THE PRE-FILLED SYRINGE OF FIBRINOGEN STILL WITH COMPONENT. IN ADDITION, THE DUAL APPLICATOR. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY FUNCTIONAL ISSUES. UPON EVALUATION OF THE DEVICE, THE ADAPTER DID NOT ATTACH PROPERLY ONTO THE SYRINGE HOLDER DUE TO WRONG POSITION OF THE PRE-FILLED SYRINGE. THERE SEEMS TO BE A MISMATCH IN THAT THE COMPLAINT IS ABOUT VSTL35, BUT WE NEVER RECEIVED THAT DEVICE. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE WRONG POSITION OF THE PRE-FILLED SYRINGE. 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: H3 H6. COMPONENT CODE, H6. TYPE OF INVESTIGATION,

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). ADDITIONAL INFORMATION: D9. 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 A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2022 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE FIBRIN SEALANT PREPARATION DEVICE WOULD NOT CONNECT PROPERLY WHEN THEY WENT TO SCREW IT ON. IT TURNED BOTH WAYS, BUT IT WOULD NOT CONNECT TO THE ACTUAL BIOLOGIC. THE CASE WAS COMPLETED WITH ANOTHER TIP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229206 VISTASEAL LAPAROSCOPIC DUAL APPLICATOR R FIBRIN SEALANT PREPARATION DEVICE MZM ETHICON INC. VSTL35 10705031462571

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown