BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SURGISTOOL

    MDR report key: 8835877 · Received July 29, 2019

    Report

    Report Number
    0001831750-2019-00692
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    April 1, 2019
    Report Date
    October 23, 2019
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FZM
    UDI-DI
    07613327282566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE IS PENDING EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT EVALUATED AS IT WAS NOT MADE ACCESSIBLE BY THE CUSTOMER. : DEVICE NOT MADE AVAILABLE BY CUSTOMER.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE JACK WAS DRIFTING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE JACK WAS DRIFTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633273 SURGISTOOL STOOL, OPERATING-ROOM FZM STRYKER MEDICAL-KALAMAZOO 07613327282566

    Patients

    Seq Age Sex Outcome Treatment
    1