BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTASEAL DUAL APPLICATOR

    MDR report key: 17329877 · Received July 14, 2023

    Report

    Report Number
    2210968-2023-05171
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    January 1, 2023
    Report Date
    November 8, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    MZM
    UDI-DI
    10705031462533
    PMA / PMN Number
    BK180287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE POSSIBLE FINISHED DEVICE LOTS, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE THE POSSIBLE BATCH NUMBERS: BATCH 3122812; MFG DATE: 02/25/2022, EXP DATE: 02/06/2027. BATCH 3112155; MFG DATE: 02/13/2022, EXP DATE: 02/14/2027. 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). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED 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: 1. IS THE USER A NEW USER TO VISTASEAL? IF NOT, HOW MANY TIMES HAVE THEY USED VISTASEAL PRIOR TO THIS EVENT? NO OR TECH HAS HANDLED VISTASEAL MANY TIMES 2. HOW MANY TIMES HAVE THEY APPLIED THE LAPAROSCOPIC TIP? SEVERAL TIMES. 3. WAS A SALES REPRESENTATIVE PRESENT DURING THE CASE WHEN THE ISSUE WAS EXPERIENCED? NO. 4. WHAT IS THE LOT NUMBER? A04G149101. 5. WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? NO. 6. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? LOCKS WERE BROKEN. 7. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? NO, PRODUCT WILL BE RETURNED 8. WHAT IS THE DEVICE RETURN STATUS? WAITING ON RETURN KIT TO ARRIVE. 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) ADDITIONAL INFORMATION: H6. TYPE OF INVESTIGATION H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE ONLY THE DUAL APPLICATOR FROM THE VSTAS1 DEVICE WAS RETURNED WITH THE LUER LOCKS DAMAGED AND THE PLUNGER DISLODGED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY FUNCTIONAL ISSUES. UPON EVALUATION OF THE DEVICE, IT WAS FUNCTIONALLY TESTED, AND THE LUERS MOVE CORRECTLY AND CAN BE BOTH TIGHTENED AND LOOSENED WITHOUT ISSUES OBSERVED. THE DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. 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 COULD NOT BE CONFIRMED. 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. DEVICE EVALUATED BY MANUFACTURER?, H6. COMPONENT CODE, H6. INVESTIGATION FINDINGS, H6. INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. WHEN THEY WENT TO UNDO THE LAPAROSCOPIC TIP ON THE VST04, IT WOULDN'T COME OFF. A NEW ONE WAS USED FOR THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693129 VISTASEAL DUAL APPLICATOR FIBRIN SEALANT PREPARATION DEVICE MZM ETHICON INC. VSTAS1 3122812 AND 3112155 10705031462533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown