BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5-POLE SPRING ARM AC 2000 15-21 KG

    MDR report key: 2083127 · Received April 12, 2011

    Report

    Report Number
    2031963-2011-00022
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT, THUS NO PATIENT DATA EXISTS. ATTEMPTS WERE MADE TO DETERMINE THE SERIAL NUMBER FOR THE DEVICE; HOWEVER, THIS INFO WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. INITIAL EVAL WAS PROVIDED VIA THE BIOMEDICAL DEPT. SHOP SUPERVISOR AT THE ACCOUNT. WHEN REPLACEMENT PARTS WERE SENT TO THE ACCOUNT, THE BIOMEDICAL STAFF COMPLETED THE REPAIR AND DISCARDED THE NON-CONFORMING CIR CLIPS. THE OPERATING ROOM ASSOCIATED WITH THIS NON-CONFORMANCE WAS NOT PROVIDED AT THE TIME OF THIS REPORT. BASED ON THE INVESTIGATION AND INFO FROM THE INITIAL REPORTER, THE DEVICE PROBLEM IS KNOWN. EVAL SUMMARY: THROUGH AN INITIAL EVAL VIA THE INITIAL REPORTER, IT WAS CONCLUDED THAT THE ACCOUNT'S BIOMEDICAL ENGINEERING DEPT WAS TROUBLESHOOTING A LIGHT THAT APPEARED TO HAVE SLID DOWN SLIGHTLY, AND THEN NOTICED THAT THE CIR CLIP HAD NOT BEEN PROPERLY SEATED AND THIS IS WHAT CAUSED THE LIGHT TO COME OUT OF ITS SPECIFIED LOCATION. THE CIR CLIP IS A CRITICAL COMPONENT THAT HOLDS THE LIGHT ASSEMBLY TO THE SPRING ARM ASSEMBLY. IF THE C-CLIP IS NOT SECURED IN ITS PROPER PLACE, THEN THERE IS A POTENTIAL SERIOUS RISK TO THE PT /USER BECAUSE THE LIGHT ASSEMBLY CAN DETACH FROM THE SPRING ARM AND HAS THE POTENTIAL TO FALL. BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER, THE LIKELY ROOT CAUSE OF THIS MALFUNCTION IS DUE TO USER MISUSE WHEN DISASSEMBLING THE DEVICE ON A SEPARATE OCCASION, AND THEN NOT SEATING THE CIR CLIP BACK TO ITS PROPER POSITION WHEN RE-ASSEMBLING THE DEVICE. HOWEVER, THIS SPECIFIC MALFUNCTION WAS IDENTIFIED PRIOR TO A PROCEDURE AND THERE WERE NO PTS INVOLVED, AND NO EVENT OCCURRED. 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 REPORTED THAT THE C-CLIP ON A SPRING ARM WAS BENT, CAUSING RESTRICTED MOVEMENT OF THE ARM. AFTER FURTHER EVAL, IT WAS DETERMINED THAT THE C-CLIP WAS NOT SEATED PROPERLY. THERE WAS NO REPORTED PT INVOLVEMENT AND NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5-POLE SPRING ARM AC 2000 15-21 KG BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA