BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    12CM IQ STANDARD

    MDR report key: 19818326 · Received July 24, 2024

    Report

    Report Number
    3015967359-2024-01341
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 30, 2024
    Report Date
    October 25, 2024
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    LFL
    UDI-DI
    07613327422467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION 1 DEVICE WAS LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED.

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE 1 EVENT WAS PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT HAD BEEN REPORTED UNDER MFR REPORT # 3015967359-2024-01031. 0 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 0 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2408561 12CM IQ STANDARD INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP VMSR 07613327422467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown