BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-SERIES

    MDR report key: 18727457 · Received February 16, 2024

    Report

    Report Number
    0002031963-2024-00001
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    February 1, 2022
    Report Date
    February 16, 2024
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    FQO
    UDI-DI
    07613327400502
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY COUNSEL THAT THE PATIENT SUSTAINED INJURIES IN AN INCIDENT WHICH OCCURRED ON (B)(6) 2022, AT (B)(6). AFTER REVIEWING OUR SERVICE COMPLAINT HISTORY FOR (B)(6) THERE WAS A FAILURE IN WHICH AN EQUIPMENT BOOM FELL TO THE GROUND, BUT AT THE TIME IT WAS REPORTED THAT THERE WAS NO PATIENT OR USERS INJURIES. WE CONTACTED A HOSPITAL CONTACT RECOMMENDED BY OUR LOCAL SALES REPRESENTATIVES TO GATHER MORE DETAILS AND WE LEARNED THAT A USER WAS INJURED WHILE PREPARING THE OPERATING ROOM FOR UPCOMING CASES. THE INJURY OCCURRED AS THE USER TRIED TO PREVENT AN EQUIPMENT BOOM FROM FALLING, USING HER BODY TO COUNTERACT ITS MOMENTUM, RESULTING IN SHOULDER AND BACK INJURIES. THE USER REQUIRED IMAGING DUE TO THE INJURIES AND TOOK A SIX-MONTH MEDICAL LEAVE FOR STRAINED MUSCLES IN THE SHOULDER AND UPPER BACK. IT WAS DETERMINED THAT THE EQUIPMENT BOOM FELL TO THE FLOOR DUE TO A STRUCTURAL ISSUE, THE CORRECT HARDWARE/BRACKET WAS NOT USED REDUCING THE STRENGTH OF THE CONNECTION. WITHOUT THE PROPER HARDWARE, THE WEIGHT OF THE BOOM EVENTUALLY CAUSED THE STRUT CHANNEL TO DEFORM AROUND THE BOLT RESULTING IN THE LOWERED BOOM. BASED ON THE INFORMATION REPORTED, THE ROOT CAUSE WAS THE HOSPITAL SUPER STRUCTURE WHICH CAUSED THE STRYKER EQUIPMENT BOOM TO FALL, THERE WAS NO EVIDENCE OF A MALFUNCTION OF A STRYKER DEVICE. THE 3RD PARTY RENOVATION COMPANY RESOLVED THE STRUCTURAL ISSUE, AND IT WAS VERIFIED BY A STRUCTURAL ENGINEER THAT THE STRUCTURE WAS ACCEPTABLE. A STRYKER FIELD SERVICE TECHNICIAN (SFST) WAS DISPATCHED TO GO ON-SITE AFTER THE STRUCTURE ISSUE WAS RESOLVED, THE SFST WAS ABLE TO CONFIRM THAT EQUIPMENT WAS OPERATIONAL. IF ANY FURTHER INFORMATION IS OBTAINED AROUND THIS EVENT, A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DUE TO THE BOOM FALLING, A NURSE HURT HER SHOULDER AND BACK. SHE WAS THEN WENT ON L&I FOR ALMOST 6 MONTHS OR MORE AND STILL HAS SOME REMNANTS PAIN ON THE SHOULDER AND BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529241 S-SERIES TABLE, OPERATING-ROOM, AC-POWERED FQO STRYKER-COMMUNICATIONS 07613327400502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other