BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW TELETOM

    MDR report key: 12929071 · Received December 3, 2021

    Report

    Report Number
    0002031963-2021-00017
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 3, 2021
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED DURING AN ACL SURGICAL CASE THE PHYSICIAN ASKED FOR THE OR TABLE TO BE ELEVATED WITH A PATIENT ON THE OR TABLE. THE OR TABLE WAS ARTICULATED UP, AND THE PATIENT'S ARM GOT CAUGHT UNDER THE TELETOM BOOM. WHEN OR STAFF ATTEMPTED TO MOVE THE BOOM, THE BOOM WOULD NOT ARTICULATE. THE OR STAFF HAD TO LOWER THE TABLE TO MOVE THE PATIENT'S ARM. THIS CAUSED AN ABRASION ON THE ARM. POST OP X-RAYS WERE PERFORMED TO CONFIRM THERE WERE NO FRACTURES TO THE ARM. THERE WERE NO REPORTED INJURIES. THE CUSTOMER WAS ABLE TO CONFIRM THAT THE SURGICAL TABLE USED WAS A SKYTRON TABLE, 3501B EZ SLIDE, S/N (B)(4).   A STRYKER FIELD SERVICE TECHNICIAN (SFST) REACHED OUT TO THE CUSTOMER AND CONFIRMED THAT THE BOOM WAS NOT ARTICULATING.  THE SFST ASKED THE CUSTOMER TO CHECK THE EMERGENCY MOTOR SHUT-OFF BUTTON ON THE BOOM AND CONFIRMED THAT IT WAS PRESSED INWARD. IF THE STOP BUTTON IS PUSHED INWARD IT TURNS OFF POWER TO THE BOOM MOTOR AND PREVENTS THE BOOM FROM ARTICULATING. THE CUSTOMER CONTACT PULLED OUT THE EMERGENCY MOTOR SHUT-OFF BUTTON AND CONFIRMED THAT THE BOOM WAS ABLE TO ARTICULATE UP/DOWN WITH NO FURTHER ISSUES. THERE WAS NO REPORTED MALFUNCTION OF A STRYKER DEVICE. THE FIELD SERVICE INVESTIGATION CAN BE REFERENCED ON SALESFORCE CASE# (B)(4).   BASED ON THE INFORMATION REPORTED, THE MOST LIKELY ROOT CAUSE WOULD BE ATTRIBUTED TO USER ERROR. IT IS POSSIBLE AT SOME POINT THE EMERGENCY MOTOR SHUT-OFF BUTTON WAS PUSHED INWARD PURPOSEFULLY TO PREVENT BOOM MOVEMENT DURING THE PROCEDURE OR ON ACCIDENT BY AN END-USER WHILE CLEANING/WIPING DOWN THE SURFACE OR BUMPED BY ANOTHER DEVICE IN THE OPERATING ROOM. MEDICAL INTERVENTION (I.E. X-RAY) WAS REQUIRED TO DETERMINE IF A SERIOUS INJURY HAD OCCURRED. THE X-RAY(S) CONFIRMED NO INJURY. THERE WAS NO REPORTED MALFUNCTION OF A STRYKER DEVICE AND NO REPORTED INJURIES. IF ANY FURTHER INFORMATION IS OBTAINED AROUND THIS EVENT, A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A PROCEDURE THE PHYSICIAN ASKED FOR THE OR TABLE TO BE ELEVATED WITH PATIENT ON THE OR TABLE. THE OR TABLE WAS ARTICULATED UP AND THEN THE PATIENT'S ARM GOT CAUGHT UNDER THE TELETOM BOOM. WHEN OR STAFF ATTEMPTED TO MOVE THE BOOM, THE BOOM WOULD NOT ARTICULATE. THE OR STAFF HAD TO LOWER THE TABLE IN ORDER TO MOVE THE PATIENT'S ARM. THIS CAUSED AN ABRASION ON THE ARM. POST OP X-RAYS WERE PERFORMED TO CONFIRM THERE WERE NO FRACTURES TO THE PATIENT. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825498 NEW TELETOM TABLE, OPERATING-ROOM, AC-POWERED FQO STRYKER-COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other