BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRING ARM, LIGHT 12-18KG

    MDR report key: 2051855 · Received March 15, 2011

    Report

    Report Number
    2031963-2011-00011
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED ON-SITE BY A FIELD SERVICE TECH ON (B)(4) 2011. INITIAL REPORTER'S OCCUPATION WAS NOT KNOWN AT THE TIME OF THIS REPORT. ATTEMPTS WILL BE MADE FOR THIS INFO. DEVICE MFR DATE IS UNK AT THE TIME OF THIS REPORT. ATTEMPTS WILL BE MADE FOR THIS INFO. EVAL SUMMARY: DURING ON-SITE EVAL BY A FIELD SERVICE TECH OF THE ORIGINAL COMPLAINT, IT WAS DISCOVERED THAT THE SNAP RING (CIRCLIP) WAS NOT IN ITS INTENDED POSITION. THE C-CLIP (OR CIR CLIP) IS A CRITICAL COMPONENT THAT HOLDS THE LIGHT TO THE SPRING ARM ASSEMBLY. IF THE C-CLIP IS NOT SECURED IN ITS PROPER PLACE, THEN THE LIGHT HAS THE POTENTIAL TO FALL. THE ROOT CAUSE OF THIS MALFUNCTION MAY BE EITHER FAULTY INSTALLATION OR ELSE USER MISUSE BY SELF-ADJUSTING THE C-CLIP NOT ACCORDING TO THE INSTALLATION INSTRUCTIONS. THIS TYPE OF MALFUNCTION POSES A POTENTIAL SERIOUS RISK TO A PT/USER IF THE LIGHT WERE TO BECOME DETACHED FROM THE SPRING ARM AND FALL. HOWEVER, THIS SPECIFIC MALFUNCTION WAS IDENTIFIED PRIOR TO A PROCEDURE AND NO PTS WERE INVOLVED AND NO ADVERSE EVENTS WERE REPORTED. THIS TYPE OF NON-CONFORMANCE WILL BE MONITORED FOR ADVERSE TRENDS. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS ORIGINALLY REPORTED THAT ONE OF THE HALOGEN LIGHTS IN AN OPERATING ROOM WAS MALFUNCTIONING, BUT THE SECOND LIGHT WAS WORKING PROPERLY. HOWEVER, UPON FURTHER EVAL FROM THE FIELD SERVICE TECH ON (B)(4) 2011, IT WAS DETERMINED THAT THE SNAP RING HAD COME LOOSE AND NOTICED THE SPRING ARM HAD DROPPED SLIGHTLY. THERE WAS NO REPORTED PT INVOLVEMENT, AND NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRING ARM, LIGHT 12-18KG BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA