BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-SERIES

    MDR report key: 10579926 · Received September 24, 2020

    Report

    Report Number
    0002031963-2020-00002
    Event Type
    Injury
    Date Received
    September 24, 2020
    Date of Event
    September 2, 2020
    Report Date
    November 20, 2020
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    FQO
    UDI-DI
    07613327400502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS FURTHER REPORTED THAT WHILE THE SURGEON WAS PERFORMING ¿A LOOP ELECTROCAUTERY EXCISION PROCEDURE. THE BOOM MIGRATED SIGNIFICANTLY, CAUSING THE LOOP THE SURGEON WAS USING TO SLICE ACROSS THE PATIENT'S CERVIX. THIS RESULTED IN A LACERATION THAT NEEDED SURGICAL REPAIR AND EXTENSION OF THE SURGICAL TIME.¿ AN EXTENSION OF TIME WAS PREVIOUSLY MENTIONED. ADDITIONALLY, THE RESULTS CODE GRID WAS UPDATED TO "CONDUCTED INTERFERENCE" TO MORE ACCURATELY DESCRIBE THE RESULTS THAT OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN OR 7 BOOM FLOATING CAUSED PATIENT INJURY WHILE CAUTERY WAS IN-USE DURING A CASE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT AN EQUIPMENT BOOMS ELECTRICAL ROTATIONAL BRAKES DISENGAGED WHEN A CAUTERIZER DEVICE WAS USED BY A PHYSICIAN. THIS RESULTED IN THE EQUIPMENT BOOM TO DRIFT HORIZONTALLY AND CAUSED UNINTENTIONAL MOVEMENT OF THE CAUTERIZER WAND, NICKING THE PATIENT, AND CAUSED EXCESSIVE BLEEDING. THE EXCESSIVE BLEEDING CAUSED ADDITIONAL MEDICAL INTERVENTION BUT CAUSED A 45-MINUTE DELAY IN SURGERY. A STRYKER FIELD SERVICE TECHNICIAN (SFST) WAS DISPATCHED TO THE ACCOUNT TO PERFORM THE INVESTIGATION. THE SFST WENT ON-SITE BUT WAS UNABLE TO RE-CREATE THE ISSUE. ALTHOUGH WE COULDN¿T CONFIRM THE ROOT CAUSE THE ISSUE IS MOST LIKELY DUE TO THE MFR CAPTIVE BOARD. THE SFST INSTALLED A NEW MFR BOARD AND CONFIRMED THAT THE BOOM WAS OPERATIONAL. IF ANY FURTHER INFORMATION IS OBTAINED A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN OPERATING ROOM 7 BOOM FLOATING CAUSED PATIENT INJURY WHILE CAUTERY WAS IN-USE DURING A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047030 S-SERIES TABLE, OPERATING-ROOM, AC-POWERED FQO STRYKER-COMMUNICATIONS 0682400550 07613327400502

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention