BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE LIGHT HANDLE COVER

    MDR report key: 6818664 · Received August 24, 2017

    Report

    Report Number
    3004605321-2017-00004
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    July 26, 2017
    Report Date
    January 29, 2018
    Manufacturer
    DEROYAL INTERCONTINENTAL, S.R.L.
    Product Code
    FTA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING THAT A LIGHT HANDLE COVER (FINISHED GOOD 26-012) WAS SHORT AND FELL ONTO THE PATIENT DURING USE. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. HOWEVER, PICTURES WERE PROVIDED AND CONFIRMED THE REPORTED ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE EVENT. HOWEVER, NO DISCREPANCIES WERE IDENTIFIED. THE RAW MATERIAL IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REPORT WAS ISSUED AND IS DUE OCTOBER 6, 2017. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. SALES AND COMPLAINTS WERE REVIEWED FOR THE PERIOD OF JANUARY 2, 2015, AND AUGUST 23, 2015. A TOTAL OF (B)(4) EACHES WERE SOLD DURING THIS PERIOD, AND TWO COMPLAINTS REPORTING A SIMILAR ISSUE WERE IDENTIFIED. THIS YIELDS A COMPLAINT-TO-SALES RATIO OF (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE DEFECTIVE COVER WAS ONLY CENTIMETERS SHORT, WHICH WOULD NOT BE NOTICEABLE DURING THE PRODUCTION PROCESS. THE OPERATORS DID NOT REALIZE THE DIFFERENCE DURING ASSEMBLY. THE RAW MATERIAL IS SUPPLIED TO DEROYAL BY BRENTWOOD INDUSTRIES, AND THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO BRENTWOOD. IN ITS RESPONSE, BRENTWOOD IDENTIFIED ADDITIONAL POTENTIAL ROOT CAUSES OF THE STERILIZATION PROCESS AND A DEFECTIVE LIGHT HANDLE ADAPTER IN THE FIELD. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, BRENTWOOD STATED IT WILL CONTINUE TO FOLLOW THE PROCEDURE OUTLINED FOR INSPECTION FREQUENCY OF THE PRODUCT FIT. ADDITIONALLY, IT WILL CONTINUE TO MONITOR PRODUCT DURING PRODUCTION UTILIZING INSPECTION PLAN AND GO/NO GAUGES THAT ARE REQUIRED FOR THE PRODUCT. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED INDICATING THAT A LIGHT HANDLE COVER (FINISHED GOOD 26-012) WAS SHORT AND FELL ONTO THE PATIENT DURING USE. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. HOWEVER, PICTURES WERE PROVIDED AND CONFIRMED THE REPORTED ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE EVENT. HOWEVER, NO DISCREPANCIES WERE IDENTIFIED. A SCAR WAS ISSUED TO BRENTWOOD AND A RESPONSE HAS BEEN RECEIVED. SALES AND COMPLAINTS WERE REVIEWED FOR THE PERIOD OF JANUARY 2, 2015, AND AUGUST 23, 2015. A TOTAL OF (B)(4) EACHES WERE SOLD DURING THIS PERIOD, AND TWO COMPLAINTS REPORTING A SIMILAR ISSUE WERE IDENTIFIED. THIS YIELDS A COMPLAINT-TO-SALES RATIO OF 0.00000127 PERCENT. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE LIGHT HANDLE COVER WAS TOO SHORT ON LIGHT HANDLE AND FELL ON THE PATIENT ON THE OPERATING ROOM TABLE.

    Description of Event or Problem · 1

    THE LIGHT HANDLE COVER WAS TOO SHORT ON LIGHT HANDLE AND FELL ON THE PATIENT ON THE OPERATING ROOM TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598848 FLEXIBLE LIGHT HANDLE COVER LIGHT, SURGICAL, ACCESSORIES FTA DEROYAL INTERCONTINENTAL, S.R.L. 26-012 44603680

    Patients

    Seq Age Sex Outcome Treatment
    1