BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTASEAL DUAL APPLICATOR

    MDR report key: 17367730 · Received July 20, 2023

    Report

    Report Number
    2210968-2023-05277
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    January 12, 2023
    Report Date
    August 17, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    MZM
    UDI-DI
    10705031462533
    PMA / PMN Number
    BK180287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. 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. 1. IS THE USER A NEW USER TO VISTASEAL? IF NOT, HOW MANY TIMES HAVE THEY USED VISTASEAL PRIOR TO THIS EVENT? 2. HOW MANY TIMES HAVE THEY APPLIED THE LAPAROSCOPIC TIP? 3. WAS A SALES REPRESENTATIVE PRESENT DURING THE CASE WHEN THE ISSUE WAS EXPERIENCED? 4. WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? 5. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? 6. WAS THE PRODUCT APPLIED ON THE PATIENT? 7. WHICH PART OF THE DUAL APPLICATOR WAS FOUND FAULTY? 8. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? ADDITIONAL INFORMATION: D4 ¿ THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE THE POSSIBLE BATCH NUMBERS: 3122812 AND 3151915. 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). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE POSSIBLE FINISHED DEVICE LOTS, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION: D4, H4 ¿ 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 3151915, MFG DATE: 06/14/2022, EXP DATE: 06/15/2027. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. WAS A SALES REPRESENTATIVE PRESENT DURING THE CASE WHEN THE ISSUE WAS EXPERIENCED? NO I WAS NOT PRESENT FOR THE CASE. 2. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? NO COMPLICATIONS FOR THE PATIENT. 3. WAS THE PRODUCT APPLIED ON THE PATIENT? THIS PRODUCT WAS NOT USED. THEY OPENED ANOTHER VISTASEAL AND LAP TIP. 4. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? YES. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: 1. IS THE USER A NEW USER TO VISTASEAL? IF NOT, HOW MANY TIMES HAVE THEY USED VISTASEAL PRIOR TO THIS EVENT? 2. HOW MANY TIMES HAVE THEY APPLIED THE LAPAROSCOPIC TIP? 3. WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? 4. WHICH PART OF THE DUAL APPLICATOR WAS FOUND FAULTY? 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: H6. MEDICAL DEVICE PROBLEM CODE

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: D9. DATE DEVICE RETURNED TO MANUFACTURER, D9. IS DEVICE RETURNED TO MANUFACTURER? INVESTIGATION SUMMARY: 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 VSTAS1 DEVICE WAS RETURNED WITH THE ADAPTER BROKEN AND NO LUER LOCK WERE RETURNED, IN ADDITION THE SPRAY AND DRIP TIP DAMAGED AND PRE-FILLED SYRINGE FILL EMPTY. DUE TO THE CONDITION OF THE RETUNED DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. AS PART OF ETHICON¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT REPORTED WAS CONFIRMED AND IT IS RELATED TO IMPROPER USE OF THE DEVICE. ONE POSSIBLE CAUSE FOR THE DAMAGE FOUND ON THE ADAPTER MAY BE EXCESSIVE EXTERNAL LOAD PLACED ON THE DEVICE. 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: D9. DEVICE AVAILABLE FOR EVALUATION?, H3. DEVICE EVALUATED BY MANUFACTURER?, H6. COMPONENT CODE, H6. TYPE OF INVESTIGATION, H6. INVESTIGATION FINDINGS, H 6. INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THE SALES REP REPORTED THAT THE VST10 COULD NOT GET TIP APPLICATOR OFF OF DEVICE. NO PATIENT CONSEQUENCES. DEVICE IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993510 VISTASEAL DUAL APPLICATOR FIBRIN SEALANT PREPARATION DEVICE MZM ETHICON INC. VSTAS1 10705031462533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown