BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERASEAL DUAL APPLICATOR CE

    MDR report key: 20072672 · Received August 26, 2024

    Report

    Report Number
    2210968-2024-08951
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 26, 2024
    Report Date
    October 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    MZM
    PMA / PMN Number
    BK180287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. ADDITIONAL INFORMATION: D4, H4 ¿ THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE THE POSSIBLE BATCH NUMBERS: BATCH 3339694 MFG DATE: 3/9/2023, EXP DATE: 3/10/2028. BATCH 3422384 MFG DATE: 10/15/2023, EXP DATE: 10/16/2028. BATCH 3360518 MFG DATE: 5/10/2023, EXP DATE: 5/11/2028. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - PENDING EVALUATION OF RETURNED DEVICE. D4: FULL UDI CURRENTLY UNAVAILABLE SINCE THE EXACT LOT OF THE SUSPECTED DEVICE CANNOT BE DETERMINED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. HOW MANY TIMES HAVE THEY APPLIED THE LAPAROSCOPIC TIP? THEY DIDN¿T APPLY THE LAPAROSCOPIC TIP. THEY PUT THE SHORT TIP BY MISTAKE AND DIDN¿T SUCCEED TO TAKE IT OFF AND TO SWITCH TO THE LAPAROSCOPIC ONE. 2. WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? NO. 3. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? NO. 4. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? 4. YES. ADDITIONAL INFORMATION: D4¿ THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE THE POSSIBLE BATCH NUMBERS: 3339694, 3360518 AND 3422384 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: FULL UDI CURRENTLY UNAVAILABLE SINCE THE EXACT LOT OF THE SUSPECTED DEVICE CANNOT BE DETERMINED. 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 VRAAS1 DEVICE WAS RETURNED WITH THE LUER LOCKS DAMAGED AND THE ADAPTER BROKEN ATTACHED TO THE SYRINGE HOLDER WITH PRE-FILLED SYRINGES FILL. IN ADDITION, THE PLUNGER BROKEN. 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. LNSTITUTO.GRIFOLS, S.A. UPON THE RECEPTION OF THE NOTIFIED INCIDENT, IT WAS REQUESTED ADDITIONAL INFORMATION SUCH AS THE EXPERIENCE OF THE USER WITH THE PRODUCT, IF ANY LEAKAGE OBSERVED AT THE CONNECTION, AS WELL AS THE AVAILABILITY OF PICTURES/SAMPLES. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THEY DO NOT APPLY THE LAPAROSCOPIC TIP. THEY PUT THE SHORT TIP BY MISTAKE AND FAILED TO TAKE IT OFF AND TO SWITCH TO THE LAPAROSCOPIC ONE. NO LEAKAGE WAS OBSERVED SOME PICTURES OF THE INVOLVED DEVICE WERE RECEIVED, AND THE SAMPLE WAS RETURNED FOR EVALUATION. ACCORDING TO OUR STANDARD PROCEDURES, IT WAS INITIATED AN INVESTIGATION FOCUSED ON THE FOLLOWING: A. EVALUATION OF THE RETURNED SAMPLE AT ETHICON FACILITIES: IT WAS RECEIVED FROM ETHICON THE INVESTIGATION RELATED TO THE RETURNED UNIT. THE INVESTIGATION CONDUCTED BY ETHICON INDICATED THE FOLLOWING: VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE DUAL APPLICATOR DEVICE WAS RETURNED WITH THE LUER LOCKS DAMAGED AND THE ADAPTER BROKEN ATTACHED TO THE SYRINGE HOLDER WITH PRE- FILLED SYRINGES FILL. IN ADDITION, THE PLUNGER BROKEN. 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. ACCORDING TO ETHICON INVESTIGATION THE EVENT REPORTED 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. B. INVESTIGATION OF THE DUAL APPLICATOR TIP: CONSIDERING THE NATURE OF THE REPORTED INCIDENCE, IT WAS REQUESTED TO ETHICON TO CARRY OUT AN INVESTIGATION OF THE BATCHES OF TIPS INVOLVED, AS ETHICON IS THE SUPPLIER OF VERASEAL DUAL APPLICATOR. THE INVESTIGATION WAS FOCUSED ON REVIEWING THE RESULTS OF BATCH RECORDS FOR THE BATCHES OF TIPS USED. IT IS CONCLUDED THAT ALL THE COMPONENTS PARTS UTILIZED FOR THE INVOLVED BATCHES MET THE ESTABLISHED SPECIFICATIONS WITH NO INCIDENTS RELATED. C. RESULTS OF QUALITY CONTROL PERFORMED AT IG FACILITIES. LNSTITUTO GRIFOLS, S.A. REVIEWED THE RESULTS OF THE QUALITY CONTROLS PERFORMED TO THE INCOMING MATERIALS (TIPS) INVOLVED IN THE NOTIFICATION. A REVIEW OF THE RESULTS RELATED TO THE LUER LOCK FUNCTIONALITY PERFORMED TO INCOMING TIPS KITTED WITH THE INVOLVED BATCH, A04J015331, WAS PERFORMED. THE RESULTS WERE FOUND CORRECT WITHIN SPECIFICATIONS AND NO DEVIATIONS WERE DETECTED. BASED ON THE INVESTIGATION PERFORMED AND THE EVALUATION OF THE RETURNED DEVICE, IT IS CONCLUDED THAT THE REPORTED NOTIFICATION IS NOT RELATED TO THE QUALITY OF THE PRODUCT OR ANY OF THE RELATED COMPONENTS. ONE POSSIBLE CAUSE FOR THE DAMAGE FOUND ON THE ADAPTER MAY BE EXCESSIVE EXTERNAL LOAD PLACED ON THE DEVICE. WE WOULD LIKE TO REMARK THE IMPORTANCE OF FOLLOWING THE LEAFLET INSTRUCTIONS AND HIGHLIGHT THE FOLLOWING INDICATION: DO NOT USE ANY EXTERNAL ELEMENT OR TOOL TO DISSEMBLE THE TIPS AND UNSCREW THE LUER LOCKS MANUALLY. 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 MINI LAP GASTRIC BYPASS PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE FIBRIN SEALANT PREPARATION DEVICE WAS OPENED TO THE SURGEON. THE SURGEON AND STAFF ARE FAMILIAR AND USE TO WORK WITH HE FIBRIN SEALANT PREPARATION DEVICE. THE COMPANY REPRESENTATIVE WAS NOT PRESENT DURING THE OPERATION. WHEN THE SURGEON TRIED TO PRESS THE SYRINGE SO THAT THE MATERIAL WOULD COME OUT, IT WOULD NOT COME OUT. AT FIRST THEY THOUGHT IT HAD NOT BEEN OPENED PROPERLY. THE SCRABBED NURSE TRIED TO OPEN THE GRAY PINS BUT IT WAS STUCK. THE SURGEON TOOK THE SYRINGE AND TRIED TO OPEN IT, FIRST WITH HIS HAND AND THEN TRIED TO DO IT WITH A GRASPER, TO HAVE A STRONGER GRIP. THAT DIDN'T HELP EITHER AND THE GRAY PINS DIDN'T MOVE AT ALL. THE SURGEON ASKED TO OPEN A TISSIL INSTEAD. THE OPERATION CONTINUED AS USUAL, THE PATIENT WAS NOT HARMED AS A RESULT OF THE MALFUNCTION. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT, AND WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940722 VERASEAL DUAL APPLICATOR CE FIBRIN SEALANT PREPARATION DEVICE MZM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown