BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTASEAL LAPAROSCOPIC DUAL APPLICATOR (45 CM FLEXIBLE)

    MDR report key: 22882599 · Received August 25, 2025

    Report

    Report Number
    2210968-2025-09718
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    January 1, 2025
    Report Date
    November 20, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    MZM
    UDI-DI
    10705031462724
    PMA / PMN Number
    BK190324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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, 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). CORRECTED INFORMATION: D 4. PRIMARY UDI NUMBER, H 3. DEVICE EVALUATED BY MANUFACTURER? ADDITIONAL INFORMATION: D 4. EXPIRATION DATE, H 4. DEVICE MANUFACTURE DATE, H 6. TYPE OF INVESTIGATION, H 6. INVESTIGATION FINDINGS, H 6. INVESTIGATION CONCLUSIONS, H 6. COMPONENT CODE H3 INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE SECONDARY BOX OF THE VSTL45 PRODUCT CODE WITH LOT: 5881559 WAS RETURNED. UPON EVALUATION OF THE PACKAGING INSIDE OF THE SECONDARY BOX, THE PRIMARY PACKAGING OF PRODUCT CODE VSTL35 WITH THE RE-LABEL OF LOT: 5881559 WAS FOUND INSIDE. AS PART OF ETHICON¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE REPORTED COMPLAINT WAS CONFIRMED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. A REVIEW OF THE DEVICE BATCH RECORD WAS PERFORMED FOR RAW MATERIALS, IN-PROCESS AND FINISHED GOODS FOR LOT NUMBER 5881559. CAPA-03781 WAS OPENED. THE DEVICES MET ALL RAW MATERIALS, IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE OF THE PRODUCT. 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). D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H6 COMPONENT CODE: G07002 - PENDING EVALUATION OF RETURNED DEVICE. 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 INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PLEASE CLARIFY, IS THIS A WAREHOUSE ORDERING ISSUE (ORDERED VSTL45 BUT RECEIVED VSTL35 PRODUCT INSTED) OR WAS A VSTL35 LAPAROSCOPIC APPLICATOR FOUND WITHIN A VSTL45 PRODUCT BOX (ASSEMBLY MANUFACTURING ISSUE)? THE PRODUCT ORDERED VSTL45 WAS DELIVERED BUT INSIDE OF 4 SEPARATE VSTL45 BOXES WAS THE WRONG PRODUCT. VSTL45 BOXES WERE STOCKED WITH VSTL35 TIPS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: ARE PICTURES AVAILABLE? WHAT IS THE DELIVERY / ORDER NUMBER? CAN YOU PLEASE PROVIDE THE INVOICE? 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ACCOUNT RECEIVED AN INCORRECT PRODUCT. OUTSIDE THE SHIPPING LABEL PRODUCT CODE IS FOR THE LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR 45CM, BUT THE ACTUAL PRODUCT THEY RECEIVED IS LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR 35CM. ADDITIONAL INFORMATION WAS REQUESTED. NO PATIENT CONSEQUENCES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2823517 VISTASEAL LAPAROSCOPIC DUAL APPLICATOR (45 CM FLEXIBLE) FIBRIN SEALANT PREPARATION DEVICE MZM ETHICON INC. 5881559 10705031462724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown