BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M5

    MDR report key: 19961759 · Received August 12, 2024

    Report

    Report Number
    1045254-2024-01243
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 16, 2024
    Report Date
    September 7, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    UDI-DI
    00643169588127
    PMA / PMN Number
    K081277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF THE DEVICE FOUND THAT ANALYSIS COULD NOT VERIFY EXCESSIVE HEAT. HANDPIECE WAS NOT RUNNING. WHEEL LOCK, MOTOR/CABLE SEALS AND BEARINGS CORRODED. 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.

    Additional Manufacturer Narrative · 0

    G4: 510K: K081277 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 DEVICE WAS OVEREHEATING DURING CUT CYCLE OF LAB USAGE. DEVICE WAS USED FOR 4 HOURS OF SIMULATED FRONTAL DRILLOUTS. DEVICE WAS SWITCHED TO ANOTHER HANDPIECE. SPEED OF DEVICE WAS 30000 RPM IN FORWARD MODE. IRRIGATION FLOW RATE WAS 10 CC/MIN. DEVICE MOTOR GOT STALLED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED AFTER FOLLOW UP THAT DEVICE WAS OVERHEATING IN LESS THAN A MINUTE BUT THE HANDPIECE WAS BEING USED ALL DAY ON SIMULATED FRONTAL DRILLOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723787 IPC® HANDPIECE - XPS® STRAIGHTSHOT® M5 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I ERL MEDTRONIC XOMED INC. 1899200 226112764 00643169588127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown