BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO RECIPROCATING SAW

    MDR report key: 2851385 · Received October 29, 2012

    Report

    Report Number
    1811755-2012-03922
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY, THIRD-PARTY REPAIR BY A NON-STRYKER ORGANIZATION WAS OBSERVED. THE INSTRUCTIONS FOR USE WARN AGAINST COMPONENT REPAIR BY OTHER SERVICE ORGANIZATIONS.

    Description of Event or Problem · 1

    THE MICRO RECIPROCATING SAW WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER, IT DISPLAYED A BIAS CURRENT ERROR WHEN CONNECTED TO THE CONSOLE, SIGNALING A RUN-ON CONDITION OCCURRED. THERE WAS NO PT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO RECIPROCATING SAW ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK