BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIS

    MDR report key: 16911325 · Received May 11, 2023

    Report

    Report Number
    0002031963-2023-00003
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    April 14, 2023
    Report Date
    May 11, 2023
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AN EQUIPMENT BOOM END CAP COVER FELL DURING A ROBOTIC HYSTERECTOMY PROCEDURE. THE COVER FELL ONTO A PATIENT, DELAYING THE SURGICAL CASE BY 20 MINUTES. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AT THE CONTACT POINT TO MINIMIZE INFECTION RISK. THERE WAS NO OPEN INCISION IN THE PATIENT AT THE TIME THE COVER FELL, BUT THE ROBOT WAS INSIDE THE PATIENT. THERE WAS NO BRUISING OR WOUND SUSTAINED FROM THE COVER FALLING, AND THERE WERE NO REPORTS OF AN INJURY. THE STRYKER FIELD SERVICE TECHNICIAN (SFST) WAS DISPATCHED TO THE ACCOUNT TO INVESTIGATE FURTHER. THE SFST CONFIRMED FROM HOSPITAL STAFF THAT THE END CAP COVER FELL DUE TO COLLISION FROM A SURGICAL LIGHT HEAD. THERE WERE NO SIGNS OF DAMAGE TO THE COVER OR THE BOOM ARMSET. THE SFST REPLACED THE COVER WITH A NEW ONE AND CONFIRMED THAT IT WAS FLUSH WITH THE ARM SET AND SEATED PROPERLY. IF FURTHER INFORMATION IS OBTAINED A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN OR 26 THE BOOM END CAP FELL ONTO PATIENT WHICH CONTAMINATED THE FIELD. THE PATIENT WAS ADMINISTERED ADDITION ANTIBIOTICS TO THE CONTACT POINT TO MINIMIZE ANY CHANCE OF AN INFECTION OCCURRING. THERE WAS NO OPEN INCISION ON THE PATIENT BUT THE ROBOT WAS INSIDE OF THE PATIENT. THERE WAS NO BRUISING OR WOUND SUSTAINED FROM CAP CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351202 FLEXIS TABLE, OPERATING-ROOM, AC-POWERED FQO STRYKER-COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other