BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON D860 SEAT,CFK,STAINLESS,POWERDRV

    MDR report key: 6425263 · Received March 22, 2017

    Report

    Report Number
    0008010153-2017-00016
    Event Type
    Malfunction
    Date Received
    March 22, 2017
    Date of Event
    February 24, 2017
    Report Date
    October 18, 2017
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE RIGHT LEG OF THE SPLIT LEG ALLEGEDLY WILL NOT STAY UP AND LOWERS SLOWLY. 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 PATIENT INVOLVEMENT, INJURY OR ADVERSE CONSEQUENCE REPORTED.

    Additional Manufacturer Narrative · 1

    A CAPA WAS INITIATED TO FURTHER INVESTIGATE THE REPORTED EVENT OF THE REPORTED UNINTENDED MOVEMENT. THROUGH INVESTIGATION, THE TABLES WERE FOUND TO MEET DESIGN SPECIFICATIONS. WITHIN THE CAPA THERE ARE MULTIPLE POTENTIAL ROOT CAUSES WHICH MAY HAVE ATTRIBUTED TO THIS COMPLAINT. AS A RESULT, EACH POTENTIAL ROOT CAUSE WAS ASSESSED AND ACTION HAVE BEEN TAKEN TO PREVENT FUTURE OCCURRENCES AS RELATED. ALSO THROUGH INVESTIGATION, ALONG WITH MULTIPLE CONSULTATIONS WITH PHYSICIANS, IT WAS DETERMINED THAT THE RISKS INVOLVED WITH THIS EVENT HAS A LIMITED SEVERITY AND A NEGLIGIBLE OCCURRENCE OF HARM ASSOCIATED WITH IT. NO INJURIES HAVE BEEN REPORTED AS A RESULT OF UNINTENDED MOVEMENT OF THE SURGICAL TABLE AND IT IS UNLIKELY THAT ANY INJURIES WOULD RESULT IF THIS EVENT WERE TO REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT LEG OF THE SPLIT LEG ALLEGEDLY WILL NOT STAY UP AND LOWERS SLOWLY. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR ADVERSE CONSEQUENCE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT LEG OF THE SPLIT LEG ALLEGEDLY WILL NOT STAY UP AND LOWERS SLOWLY. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207123 OPERON D860 SEAT,CFK,STAINLESS,POWERDRV TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1