BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAONE

    MDR report key: 23176785 · Received September 30, 2025

    Report

    Report Number
    9612501-2025-02547
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 10, 2025
    Report Date
    December 9, 2025
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GCJ
    PMA / PMN Number
    K130435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6 CORRECTION: E1 (STREET 1). H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. DURING FUNCTIONAL TESTING, THE DEVICE PASSED AN AIR LEAK TEST. THE DUCKBILL SEAL FAILED DURING MANUAL MANIPULATION. THE SEAL HOUSING WAS BROKEN OPEN TO REMOVE THE CIRCULAR SEAL TO CHECK FOR SUBASSEMBLY OVERALL HEIGHT. THE MEASUREMENTS WITH CALIPERS WERE, 254, 254, 254, 253, 254, AND 253. IT WAS REPORTED THAT THE TROCAR EXHIBITED A DAMAGED SEAL WHILE THE TROCAR WAS IN THE ABDOMEN, AND THE SEAL WAS FOUND TO BE LEAKY. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. INTERNAL PROCESS IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS ISSUE. 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

    D10 CONCOMITANT PRODUCTS: ONB12STF, ONB12STF VERSAONE OPT 12 STD TROCAR, (LOT# J5F2543Y) ONB12STF, ONB12STF VERSAONE OPT 12 STD TROCAR, (LOT# J5F2543Y) 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 LAPAROSCOPIC APPENDECTOMY AND CHOLECYSTECTOMY, THE THREE TROCARS EXHIBITED A DAMAGED SEAL WHILE THE TR OCAR WAS IN THE ABDOMEN. AFTER CHANGING THE INSTRUMENT, THE SEAL WAS FOUND TO BE LEAKY. A NEW SEAL WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409546 VERSAONE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ DAVIS & GECK CARIBE LTD ONB12STF J5F2543Y

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11