BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAONE

    MDR report key: 21682822 · Received March 24, 2025

    Report

    Report Number
    9612501-2025-00836
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    March 17, 2025
    Report Date
    June 12, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE SEAL HOUSING, STOPCOCK, CANNULA AND DUCKBILL SEAL WERE INTACT. THE CIRCULAR SEAL HAD A CUT. FUNCTIONAL TESTING FOUND THAT THE DEVICE PASSED AN AIR LEAK TEST. HOWEVER THE DUCKBILL SEALS FAILED UNDER MANUAL MANIPULATION WITH AN ENDO PEANUT. THE SEAL HOUSING WAS BROKEN OPEN TO REMOVE THE CIRCULAR SEAL TO CHECK FOR SUBASSEMBLY OVERALL HEIGHT. (255 MAX - 245 MIN) THE MEASUREMENTS WITH CALIPERS WAS; 258, 259, 258, 260, 254, 259. IT WAS REPORTED THAT THERE WAS A RAPID LOSS OF PNEUMOPERITONEUM. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IT WAS ALSO REPORTED THAT THERE WAS A LEAK. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. INTERNAL PROCESS IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS ISSUE. THE EVALUATION DETECTED AN UNREPORTED CONDITION: CIRCULAR SEAL WAS CUT. THIS ISSUE CAN OCCUR WHEN CONTACT IS MADE WITH A SURGICAL INSTRUMENT DURING C LINICAL APPLICATION. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: USE SPECIAL CARE WHEN INTRODUCING OR REMOVING SHARP-EDGED OR SHARP-ANGLED ENDOSCOPIC INSTRUMENTS TO MINIMIZE THE POTENTIAL OF INADVE RTENT DAMAGE TO THE SEAL. 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

    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 GASTRIC BYPASS LAPAROSCOPIC PROCEDURE, A LOT OF CARBON DIOXIDE (CO)2 INSUFFLATION GAS LEAKED FROM THE SEAL OF THE DEVICE. THE LEAKAGE OCCURRED WHILE THE PATIENT WAS INSUFFLATED AND THROUGHOUT THE PROCEDURE. IT WAS NOTED THAT THERE WAS RAPID LOSS OF PNEUMOPERITONEUM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584906 VERSAONE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ DAVIS & GECK CARIBE LTD ONB12STF J3G1717Y 10884521657687

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown