BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTASEAL LAPAROSCOPIC DUAL APPLICATOR (45 CM FLEXIBLE)

    MDR report key: 22436540 · Received July 8, 2025

    Report

    Report Number
    2210968-2025-07937
    Event Type
    Malfunction
    Date Received
    July 8, 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
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 - DEVICE NOT RETURNED. 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: PLEASE CLARIFY, WAS THE SHIPPING BOX LABELLED AS VSTL45, BUT A VSTL35 PRODUCT BOX WAS FOUND WITHIN HOLDING A VSTL35 LAPAROSCOPIC APPLICATOR OR WAS THE INCORRECT PRODUCT. (VSTL35) FOUND WITHIN A VSTL45 PRODUCT BOX? YES, A VSTL45 BOX HAD THE WRONG PRODUCT. IT HAD 3 VSTL35 LAP APPLICATORS INSTEAD OF 3 VSTL45 LAP APPLICATORS. ¿ WHAT IS THE LOT NUMBER? 5881559. ¿ WAS THE PRODUCT SEAL ON THE BOX STILL INTACT WHEN THE PACKAGE WAS OPENED? YES, SEAL WAS INTACT. 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, 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. H 6. INVESTIGATION FINDINGS: C22 ¿ PHOTO INVESTIGATION C22 PHOTO INVESTIGATION SUMMARY ==> ACCORDING TO THE INFORMATION RECEIVED, THAT WHEN THEY OPENED THE BOX THAT CAME WITH VSTL45 OUTSIDE THE SHIPPING LABEL, THE ACTUAL DEVICE RECEIVED (VSTL35) WAS INCORRECT . NO PRODUCT IS AVAILABLE FOR RETURN. NO PATIENT WAS INVOLVED. THEY JUST WANTED TO REPORT WHAT HAPPENED. THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOWS TWO SALES UNIT BOXES WITH VSTL35 PRODUCT CODES, THE LOT 5881559 #, EXPIRATION DATE 2028-03-31, PACKAGING INFORMATION. BASED ON THE PHOTO REVIEW, THE EVENT REPORTED IS NOT CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE DEVICE WAS NOT RETURNED OUR EVALUATION IS LIMITED. WE VALUE THE OPPORTUNITY TO FULLY ANALYZE THE DEVICE UPON ITS RETURN. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. WE VALUE YOUR ASSISTANCE IN PROVIDING US AN OPPORTUNITY TO EVALUATE THE REPORTED EVENT AS ALL INFORMATION REPORTED TO OUR COMPANY IS CRITICAL TO OUR CONTINUOUS IMPROVEMENT EFFORTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND FIBRIN SEALANT PREPARATION DEVICE WAS USED. WHEN THEY OPENED THE BOX THAT CAME WITH THE FIBRIN SEALANT DEVICE OUTSIDE THE SHIPPING LABEL, THE ACTUAL DEVICE RECEIVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387576 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