BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED FOCUS HEADLIGHT CAMERA SYSTEM (PAL)(OUS)

    MDR report key: 10237645 · Received July 6, 2020

    Report

    Report Number
    2523190-2020-00070
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Report Date
    June 8, 2020
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UDI # (B)(4). FIXED FOCUS HEADLIGHT CAMERA SYSTEM WAS NOT RETURN FOR EVALUATION, IMAGES EVALUATED: INADEQUATE LIGHT OUTPUT WAS FOUND TO BE A CUSTOMER PREFERENCE ISSUE. CUSTOMER PREFERRED A DIFFERENT PRODUCT. PER THE PROVIDED IMAGES, CAMERA WAS OUT OF FOCUS AND THE HEADLIGHT SCREW WAS LOOSENED DUE TO NORMAL WEAR. CAMERA FOCUS WOULD REQUIRE ADJUSTMENT AND SCREW WOULD REQUIRE REPAIR. CONCLUSION: THE REPORTED COMPLAINT IS CONFIRMED FROM THE EVALUATION. CAMERA WAS OUT OF FOCUS AND MISALIGNED DUE TO NORMAL WEAR. NO MANUFACTURING, WORKMANSHIP OR MATERIAL DEFICIENCY IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG. REPORT NUMBER: 2523190-2020-00069.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS. IT WAS REPORTED THAT AS THE HOSPITAL SURGEON STARTED USING THE 003285PAL FIXED FOCUS HEADLIGHT CAMERA SYSTEM, HE FOUND A QUALITY DEVIATION BETWEEN THE NEW SYSTEM AND THE OLD ONE. THE BASIC FINDINGS WERE AS FOLLOWS: THE OLD HEADLIGHT HAS A LARGER BEAM AND COVERS A LARGE SURGICAL FIELD AND DOES NOT HAVE A ROUND PERIPHERY APPEARING IN THE SCREEN; THE CAMERA WAS OUT OF FOCUS AND THE CAMERA FITTING WAS LOOSE; THE ALIGNMENT SCREWS NEEDED TO BE FIXED PROPERLY. THERE WAS NO INJURY FOR THE PATIENT BUT LOT OF DISCOMFORT FOR THE SURGEON. THERE WAS A SURGERY DELAY OF 45 MINUTES DUE TO DEVICE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701893 FIXED FOCUS HEADLIGHT CAMERA SYSTEM (PAL)(OUS) LIGHTING CAMERA FWC INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1