BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2507735 · Received March 1, 2012

    Report

    Report Number
    1221826-2012-00008
    Event Type
    Other
    Date Received
    March 1, 2012
    Date of Event
    January 30, 2012
    Report Date
    February 28, 2012
    Manufacturer
    KARL STORZ ENDOVISION .
    Product Code
    FFS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    I HAVE FILED THIS SUPPLEMENTAL TO MDR 12-08 (CFN: 1221826-2012-00008) TO REPORT THAT A POSSIBLE CAUSE FOR THE POWER ASSEMBLY BEING DEFECTIVE WAS THE USE OF COUNTERFEIT CAPACITOR CHIPS PROVIDED BY THE SUPPLIER. THE ISSUE WAS ADDRESSED THROUGH A CAPA.

    Additional Manufacturer Narrative · 1

    EVAL STATES THAT THE POWER SUPPLY IS DEFECTIVE AND IT WILL NOT IGNITE THE LAMP. LAMP IS BURNED AND LIGHT OUTPUT IS VERY LOW.

    Description of Event or Problem · 1

    PT WAS PREPPED FOR A THERMACHOICE ABLATION PROCEDURE, AND THE LIGHT SOURCE STOPPED WORKING. HOSPITAL DID NOT HAVE A BACKUP LIGHT SOURCE, SO THE DOCTOR CANCELLED THE PROCEDURE AND RESCHEDULED IT.

    Description of Event or Problem · 1

    AFTER REMEDIATION OF THIS MDR, IT WAS DETERMINED THAT WE SHOULD FILE A SUPPLEMENTAL. I AM FILING THE SUPPLEMENTAL TO ADD INFORMATION ON POSSIBLE CAUSE OF DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LIGHT SOURCE, 175W NOVA FFS KARL STORZ ENDOVISION . 201315-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other