BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAMANTYS MBS W/ LIGHT

    MDR report key: 22892147 · Received August 26, 2025

    Report

    Report Number
    1723170-2025-03068
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    June 5, 2025
    Report Date
    August 26, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEI
    UDI-DI
    00763000280918
    PMA / PMN Number
    K073495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: CANNOT CONFIRM COMPLAINT. UPON RECEIVING THE DEVICE THE TUBING WAS CUT AND UNABLE TO CONDUCT ANALYSIS. THE DEVICE WAS DECONTAMINATED. H6: CODES B01, C07 D02 ARE APPLICABLE. 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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE HANDPIECE FAILED TO PRIME AND THERE WAS NO SALINE FLOW IN TUBING. INITIALLY TUBING WAS PLACED INTO THE PUMP SEGMENT AND THE PRIME BUTTON WAS PRESSED. THE PUMP SEGMENT ROLLERS WERE AUDIBLY TURNING INSIDE BUT THERE WAS NO FLUID MOVEMENT. THE PRIME FEATURE WAS STOPPED AND THE TUBING WAS REMOVED FROM THE PUMP. TROUBLESHOOTING METHODS WERE PERFORMED WITH TUBING REMOVED AND PRIME BUTTON PRESSED BRIEFLY WITH THE PUMP SEGMENT OPEN TO VISUALLY INSPECT MOVEMENT OF THE ROLLERS (NO ISSUE NOTED), THE IV BAG WAS SQUEEZED BUT NO FLUID WAS PASSING THROUGH THE TUBING, A NEW 1000ML BAG OF SALINE WAS SPIKED AND THE DRIP CHAMBER WAS SQUEEZED BUT DID NOT MOVE FLUID DOWN THE TUBING, A FINAL ATTEMPT WAS MADE BY PLACING THE TUBING BACK INTO THE PUMP SEGMENT BUT THE TUBING WOULD NOT PRIME OR DELIVER FLUID TO THE TIP OF THE DEVICE. FAILED TO RESOLE THE ISSUE AFTER MULTIPLE ATTEMPTS. A NEW HANDPIECE WAS DELIVERED TO THE STERILE FIELD AND THEN CONNECTED TO THE AEX GENERATOR, IT WORKED WITHOUT ISSUE. NO REPORTED IMPACT ON PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SURGERY PERFORMED AT THE TIME OF EVENT OCCURRED WAS AN ANTEROLATERAL APPROACH TO A TOTAL HIP ARTHROPLASTY AND THERE WAS A MINOR SURGICAL DELAY OF 3 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2778978 AQUAMANTYS MBS W/ LIGHT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI MEDTRONIC NAVIGATION, INC 23-301-1 PHC1025C 00763000280918

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male