BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON D860 SEAT,CFK,STAINLESS,POWERDRV

    MDR report key: 6168049 · Received December 12, 2016

    Report

    Report Number
    0008010153-2016-00107
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 15, 2016
    Report Date
    February 2, 2017
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE D860 OR TABLE (SN (B)(4)) MOVED AFTER A BUTTON ON THE HAND PENDANT WAS RELEASED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE HEALTH CONSEQUENCES REPORTED. THE OR TABLE WAS INSPECTED BY A STRYKER FIELD SERVICE TECHNICIAN (SFST). THE SFST DETERMINED THE TABLE NEEDED THE SLIDE MOTOR REPLACED DUE TO A BROKEN SLIDE MOTOR BELT AS WELL AS NEW CONFIGURATION FILES LOADED AND CYCLE TEST RUN TO VERIFY FUNCTIONALITY. THE SFST REPLACED SLIDE MOTOR, TESTED AND ADJUSTED SLIDE LIMITS, SAVED OLD CONFIGURATION FILES AND SAVED ERROR FILES. THE SFST LOADED NEW CONFIGURATION FILES, SET TABLE SLIDE LIMITS AND LEVEL, RAN CYCLE TEST AND THEN RAN THE TABLE THROUGH 2 LOOPS OF CYCLE TEST WITH NO ERRORS. THE TABLE WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE SLIDE MOTOR ASSEMBLY WAS NOT RETURNED TO STRYKER FLOWER MOUND FOR FURTHER INVESTIGATION. THE DHR AND FINAL INSPECTION RESULTS WERE REVIEWED. THERE WERE NO FAILURES NOTED. THE OR TABLE (SN (B)(4)) WAS MANUFACTURED IN JULY 2016. THE DIRECT CAUSE OF THE UNINTENDED TABLE MOVEMENT WAS DUE TO THE HAND PENDANT. THE ROOT CAUSE OF THE HAND PENDANT FAILURE IS SOFTWARE RELATED AS IT WAS CORRECTED BY LOADED A NEW CONFIGURATION FILE. THE ROOT CAUSE OF THE SLIDE MOTOR ASSEMBLY FAILURE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE TWO NEW OPERON D860 TABLES ALLEGEDLY CONTINUE TO MOVE AFTER THE SWITCH ON THE HAND PENDANT IS RELEASED. AFTER FURTHER DISCUSSIONS WITH THE CUSTOMER, IT WAS FOUND TO BE WITH ONE TABLE, ENDING IN SERIAL NUMBER (B)(4). THE INVESTIGATION ON THE DEVICE IS ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL WILL BE FILED TO INCLUDE THE INVESTIGATION RESULTS. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR ADVERSE CONSEQUENCE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TWO NEW OPERON D860 TABLES ALLEGEDLY CONTINUE TO MOVE AFTER THE SWITCH ON THE HAND PENDANT IS RELEASED. AFTER FURTHER DISCUSSIONS WITH THE CUSTOMER, IT WAS FOUND TO BE WITH ONE TABLE, ENDING IN SERIAL NUMBER (B)(4). THERE WAS NO PATIENT INVOLVEMENT, INJURY OR ADVERSE CONSEQUENCE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TWO NEW OPERON D860 TABLES ALLEGEDLY CONTINUE TO MOVE AFTER THE SWITCH ON THE HAND PENDANT IS RELEASED. AFTER FURTHER DISCUSSIONS WITH THE CUSTOMER, IT WAS FOUND TO BE WITH ONE TABLE, ENDING IN SERIAL NUMBER (B)(4). THERE WAS NO PATIENT INVOLVEMENT, INJURY OR ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817999 OPERON D860 SEAT,CFK,STAINLESS,POWERDRV TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1