BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI-1000

    MDR report key: 8614117 · Received May 15, 2019

    Report

    Report Number
    2028295-2018-00005
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    March 1, 2018
    Report Date
    March 27, 2018
    Manufacturer
    MEDICAL ILLUMINATION INTRNATION INC.
    Product Code
    FST
    PMA / PMN Number
    K100388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARM SUPPORT FITTING SPECIFIED IN CUSTOMER COMPLAINT (B)(4) WAS RECEIVED INTO ENGINEERING 03/20 FOR ANALYSIS. THE FINISHED PRODUCT WAS A DUAL MI-1000 MODEL (061515-V / S/N (B)(4)). THE COMPONENT WAS VISUALLY INSPECTED AND FOUND TO HAVE FAILED ON THE 1002036 LOWER TAG. OTHER THAN NORMAL WEAR-AND TEAR, NO OTHER DAMAGE WAS OBSERVED. HAVING SEEN THREE OTHER SIMILAR FAILURES WITHIN THE PAST NINE MONTHS, WE REVIEWED THE MANUFACTURING DATE OF ALL UNITS. NONE OF THE MANUFACTURED DATES WERE WITHIN THE SAME BUILD GROUPS AND THE COMPONENTS WERE FROM DIFFERENT BATCHES. WE DID MULTIPLE CROSS-SECTION CUTS TO RULE OUT POROSITY AS A CAUSE OF FAILURE. THE MATERIAL POROSITY LOOKED NORMAL AND NE STRESS-RELATED FACTORS WERE FOUND. WE REVIEWED THE LOCATION OF THE FAILURE AND WHILE IN THE SAME LOCATION, THE FAILURE WAS CLOSER TO THE COMPONENT MOUNTING BOLT. WE INQUIRED TO THE END-USER IF THE UNIT HAD BEEN EXPOSED TO ANY STRESS OF IT THE SPRING ARM IMPACTED THE STOP AT A SIGNIFICANT FORCE. THE STAFF STATED THAT IT WAS NOT EXPOSED TO ANY UNREASONABLE FORCE. WE COULD NOT DETERMINE THE EXACT CAUSE OF THE FAILURE OF THE 1002036 ARM SUPPORT FITTING. WE SPECULATE THAT THERE IS A POSSIBILITY THAT IN ORDER TO ELIMINATE ANY HORIZONTAL DRIFT IN THE SPRING ARM, THE END-USER TRIED TIGHTING THE CLENCHING BOLT AND THE BOLT WAS INADVERTENTLY OVER-TIGHTENED TO A POINT OF OVERSTRESSING THE 1002036 TANGS CAUSING THE BREAK. THIS SPECULATION IS FROM THE FACT THAT THE FAILURE WAS CLOSER TO THE THROUGH HOLE OF THE CLENCHING BOLT.

    Description of Event or Problem · 1

    ON (B)(6) 2018 AN INCIDENT WAS REPORTED TO MEDICAL ILLUMINATION REGARDING AN MI-1000 ARM SUPPORT FITTING FRACTURING CAUSING THE LIGHT TO FALL. IT WAS STATED ONE OF THE TECHNICIANS WAS STRCUK IN THE HEAD, AS A RESULT HAD A MINOR BUMP ON HIS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404028 MI-1000 MINOR SURGICAL LIGHT FST MEDICAL ILLUMINATION INTRNATION INC. 061515-V

    Patients

    Seq Age Sex Outcome Treatment
    1