BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAONE

    MDR report key: 22263964 · Received June 18, 2025

    Report

    Report Number
    9612501-2025-01550
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    June 10, 2025
    Report Date
    October 13, 2025
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GCJ
    UDI-DI
    10884521657687
    PMA / PMN Number
    K130435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. A VIDEO WAS ALSO PROVIDED. VISUAL INSPECTION NOTED THAT THE OBTURATOR WAS NOT RECEIVED. THE SEAL HOUSING, CIRCULAR SEAL, STOPCOCK, DUCKBILL SEAL AND CANNULA APPEARED INTACT. FUNCTIONAL TESTING NOTED THAT THE DEVICE PASSED THE AIR LEAK TEST. THE DUCKBILL SEAL FAILED DURING MANUAL MANIPULATION USING AN ENDO PEANUT. THE SEAL HOUSING WAS BROKEN OPEN TO REMOVE THE CIRCULAR SEAL TO CHECK FOR SUBASSEMBLY OVERALL HEIGHT. THE MEASUREMENTS WITH CALIPERS WERE 251, 253, 255, 251, 252 AND 255. IT WAS REPORTED THAT THE SEAL WAS DAMAGED AND THERE WERE LEAKS. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. H3. EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE INVOLVED DEVICE WAS NOT RETURNED. HOWEVER, A VIDEO WAS PROVIDED. VISUAL INSPECTION NOTED THAT THE VIDEO SHOWS THE SURGEON REMOVING THE SEAL HOUSING AND PRESSING THE CENTER OF THE SEAL. DUE TO THE QUALITY OF THE VIDEO IT IS NOT POSSIBLE TO CONFIRM THE REPORTED CONDITION. IT WAS REPORTED THAT SEAL WAS DAMAGED AND THERE WAS AN AIR LEAKAGE. THE REPORTED ISSUES WERE NOT CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BARIATRIC LAPAROSCOPIC PROCEDURE, THE SEAL WAS DAMAGED THAT RESULTED TO A GAS LEAK FROM THE SEAL OF THE BLADELESS TROCAR WHILE THE DEVICE WAS BEING APPLIED DURING THE HEMOSTASIS STEP. THE TROCAR CANNULA WAS REPLACED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344603 VERSAONE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ DAVIS & GECK CARIBE LTD ONB12STF J4C2940Y 10884521657687

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female