BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON D 830 SEAT, CFK, STAINLESS

    MDR report key: 6283750 · Received January 27, 2017

    Report

    Report Number
    0008010153-2017-00003
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Date of Event
    January 9, 2017
    Report Date
    May 12, 2017
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE TABLE ALLEGEDLY DRIFTS INTO TREND POSITION ON ITS OWN. A STRYKER FIELD SERVICE TECHNICIAN (SFST) WAS DISPATCHED TO THE CUSTOMER. WHILE ONSITE, THE SFST WAS ABLE TO REPRODUCE THE COMPLAINT. THE TABLE IS SCHEDULED TO BE RETURNED TO STRYKER FOR FURTHER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL WILL BE FILED. THERE WAS NO INJURY, SURGICAL DELAY OR ADVERSE CONSEQUENCE REPORTED.

    Additional Manufacturer Narrative · 1

    THE TABLE WAS RECEIVED IN FLOWER MOUND FOR REPAIR. THE TREND CYLINDER WAS REPLACED AND THE TABLE WAS VERIFIED TO BE FUNCTIONING AS INTENDED PRIOR TO RELEASE TO THE CUSTOMER. THE DIRECT CAUSE OF THE UNINTENDED MOTION WAS DUE TO THE TREND CYLINDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE ALLEGEDLY DRIFTS INTO TREND POSITION ON ITS OWN. THERE WAS NO INJURY, SURGICAL DELAY OR ADVERSE CONSEQUENCE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE ALLEGEDLY DRIFTS INTO TREND POSITION ON ITS OWN. THERE WAS NO INJURY, SURGICAL DELAY OR ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64975 OPERON D 830 SEAT, CFK, STAINLESS TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1