BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON D 860 SEAT, CFK, STAINLESS

    MDR report key: 14117602 · Received April 15, 2022

    Report

    Report Number
    0008010153-2022-00007
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 24, 2022
    Report Date
    April 15, 2022
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    UDI-DI
    07613327170160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AN OPERON D860 SURGICAL TABLE WITH SERIAL NUMBER (B)(4), WHEN ARTICULATING INTO A TRENDELENBURG POSITION, HAD THE BACK SECTION BECOME DISENGAGED. THE BACK SECTION WAS RESECURED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. AFTER FURTHER CONSULTATION WITH THE CUSTOMER IT WAS DETERMINED THAT THE PATIENT¿S ORGANS WERE EXPOSED DURING THE ALLEGED INCIDENT. A STRYKER FIELD SERVICE TECHNICIAN (SFST) WAS DISPATCHED, INSPECTED THE TABLE, AND FOUND THE BACK SECTION WAS CONNECTED PROPERLY AND AT THAT TIME THERE WERE NO ISSUES WITH THE TABLE. AFTER FURTHER INSPECTION IT WAS DETERMINED THAT THE REPORTED ISSUE EXPERIENCED IS DUE TO WEAR/DAMAGE OF THE CHANNELS OF THE DETACHABLE BACK SECTION. A NEW BACK SECTION WAS ORDERED FOR THE CUSTOMER. ON 28MAR2022 THE BACK SECTION WAS RECEIVED AND REPLACED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT DURING THE ALLEGED INCIDENT DUE TO THE ISSUE OCCURRING DURING A PROCEDURE, HOWEVER THERE WAS NO REPORTED INJURIES OR ADVERSE CONSEQUENCES TO THE PATIENT OR STAFF. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED. THERE WERE NO FAILURES NOTED DURING THE MANUFACTURING OR FINAL QUALITY INSPECTION PROCESS. THE MOST PROBABLE ROOT CAUSE FOR THIS ALLEGED INCIDENT IS NORMAL WEAR OF THE BACK SECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BACK SECTION OF THE D860 TABLE CAME OFF WHEN PUTTING IT INTO THE TREND POSITION. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136977 OPERON D 860 SEAT, CFK, STAINLESS TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG OT 8602065 07613327170160

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown