BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLD LIGHT FOUNTAIN XENON 100 SCB

    MDR report key: 17326741 · Received July 14, 2023

    Report

    Report Number
    9610617-2023-00158
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    June 26, 2023
    Report Date
    November 6, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCT
    UDI-DI
    04048551062838
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ITEM IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    DURING THE PRODUCT INSPECTION OF THE RETURNED LIGHT SOURCE, IT WAS FOUND THAT THE LAMP DOES NOT START BECAUSE THE GLASS BODY OF THE LAMP IS BROKEN. THE BULB HOLDER HAS BROKEN OUT OF THE SOCKET AND IS MOVING FREELY ON THE UNDERSIDE OF THE HOUSING. SCRATCH MARKS CAN BE SEEN ON THE UNDERSIDE OF THE HOUSING, INDICATING THAT THE BULB MUST HAVE BROKEN OFF OVER A LONGER PERIOD OF TIME. AFTER REPLACING THE XENON LAMP, THE LIGHT SOURCE WORKED PERFECTLY AGAIN. THE DEVICE HAS NOT BEEN REPAIRED AT KARL STORZ SINCE IT WAS DELIVERED TO THE CUSTOMER IN DECEMBER 2014. BASED ON THE GIVEN FACTS, THE MOST PROBABLE CAUSE IS WEAR AND TEAR. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LAMP WAS USED IN A VETERINARY LAPAROSCOPIC SPAY OPERATION OF A DOG. AFTER THE LAMP FAILED, THE OPERATION WAS TURNED IN AN OPEN SURGERY, SO IT TURNS ALSO FROM AN OVARIECTOMY TO AN OVARIOHYSTERECTOMY. THE IFU STATED THAT IT IS ONLY ALLOWED TO USE THE DEVICE IN HUMAN MEDICAL APPLICATION (ESPECIALLY GASTROENTEROLOGY). IN ADDITION, NO EVENT (TIMEFRAME: BETWEEN 2021-06-28 AND 2023-07-11) THAT COULD BE CONSIDERED AS SIMILAR TO THIS ONE AND CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY COULD BE FOUND. ALTHOUGH THE INSTRUMENT WAS USED OFF-LABEL THE CASE DEEMED REPORTABLE BECAUSE THE CASE HAD TO BE CONVERTED TO AN OPEN SURGERY DUE TO THE LOSS OF LIGHT, WHICH COULD ALSO HAPPEN DURING HUMAN APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208697 COLD LIGHT FOUNTAIN XENON 100 SCB COLD LIGHT FOUNTAIN XENON 100 SCB GCT KARL STORZ SE & CO. KG 20132620-1 04048551062838

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown