BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAMANTYS 6.0 BIPOLAR SEALER

    MDR report key: 19173422 · Received April 24, 2024

    Report

    Report Number
    1226420-2024-00020
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    April 12, 2024
    Report Date
    August 14, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEI
    UDI-DI
    00763000280888
    PMA / PMN Number
    K052859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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: UPON TESTING THE COMPLAINT WAS CONFIRMED. UPON RECEIVING THE DEVICE, IT LOOKED UNUSED WITH NO DAMAGE. THE DEVICE WAS DECONTAMINATED AND THEN TESTED PER WI. UPON VISUAL INSPECTION THERE WAS A HAIR IN THE PACKAGING. H6: CODES B01, C160503 D03 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR PREOPERATIVELY. IT WAS REPORTED THAT HAIR WAS FOUND IN STERILE PACKAGING. THE HANDPIECE WAS NOT USED. ANOTHER PACKAGE WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190025 AQUAMANTYS 6.0 BIPOLAR SEALER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC NAVIGATION, INC 23-112-1 PHL2723B 00763000280888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown