BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT SOURCE "OLYMPUS CLL-V1", LED, 110-230 V

    MDR report key: 6759403 · Received August 2, 2017

    Report

    Report Number
    9610773-2017-00097
    Event Type
    Injury
    Date Received
    August 2, 2017
    Report Date
    November 28, 2017
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    NTN
    PMA / PMN Number
    PK130819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LIGHT SOURCE WAS RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. WHEN THE DEVICE WAS INSPECTED AND TESTED, IT WAS FOUND TO BE IN GOOD WORKING ORDER AND IN ACCORDANCE WITH ITS SPECIFICATIONS. NO ABNORMALITY, DEFECT, FAILURE OR MALFUNCTION WAS FOUND DURING THE PERFORMANCE TESTS. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE LIGHT SOURCE DID NOT ACTUALLY MALFUNCTION DURING THE PROCEDURE. IN FACT, THE ILLUMINATION OF THE OPERATING FIELD WAS MERELY PERCEIVED AS INSUFFICIENT. ANOTHER LIGHT SOURCE OF THE SAME MODEL PRESENT IN THE OPERATING ROOM WAS NOT USED SINCE IT WAS NOT EXPECTED TO PROVIDE SUFFICIENT ILLUMINATION. IN ADDITION, A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE LIGHT SOURCE WITHOUT SHOWING ANY ABNORMALITIES RELATED TO FUNCTION AND SAFETY. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS. HOWEVER, THE EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS, THE INTENDED USE OF THE LIGHT SOURCE AND ITS TECHNICAL LIMITATIONS.

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEVICE RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE LIGHT SOURCE DID NOT ACTUALLY MALFUNCTION DURING THE PROCEDURE. IN FACT, THE ILLUMINATION OF THE OPERATING FIELD WAS MERELY PERCEIVED AS INSUFFICIENT. ANOTHER LIGHT SOURCE OF THE SAME MODEL PRESENT IN THE OPERATING ROOM WAS NOT USED SINCE IT WAS NOT EXPECTED TO PROVIDE SUFFICIENT ILLUMINATION. IN ADDITION, A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE LIGHT SOURCE WITHOUT SHOWING ANY ABNORMALITIES RELATED TO FUNCTION AND SAFETY. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS. HOWEVER, THE EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS, THE INTENDED USE OF THE LIGHT SOURCE AND ITS TECHNICAL LIMITATIONS.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC ENDOSCOPIC PROCEDURE, THE LIGHT SOURCE MALFUNCTIONED. AS A RESULT, THE OPERATING FIELD WAS NOT ILLUMINATED ANYMORE AND THE ENDOSCOPIC PROCEDURE HAD TO BE CONVERTED TO OPEN SURGERY. FURTHERMORE, IT WAS REPORTED THAT ANOTHER LIGHT SOURCE OF THE SAME MODEL WAS NOT FUNCTIONING EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542268 LIGHT SOURCE "OLYMPUS CLL-V1", LED, 110-230 V DESKTOP LIGHT SOURCES NTN OLYMPUS WINTER & IBE GMBH WA97020A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention