BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT GUIDE, SIZE S, PLUG TYPE, 3 M, CF TYPE

    MDR report key: 6448954 · Received March 31, 2017

    Report

    Report Number
    9610773-2017-00051
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    March 16, 2017
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    EWY
    PMA / PMN Number
    PK912362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEVICE RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION SINCE THE RELEVANT LIGHT-GUIDE CABLE COULD NOT BE IDENTIFIED AT THE USER FACILITY. FURTHERMORE, A MANUFACTURING AND QUALITY CONTROL REVIEW COULD NOT BE PERFORMED SINCE BASIC DATA OF ARTICLE IDENTIFICATION (LOT NUMBER) ARE MISSING. HOWEVER, AS CLEARLY STATED AS A WARNING NOTE IN THE INSTRUCTIONS, THE TELESCOPE'S DISTAL END OR THE LIGHT-GUIDE CONNECTOR MUST NOT BE PLACED ON THE PATIENT'S SKIN, ON FLAMMABLE MATERIALS OR ON HEAT-SENSITIVE MATERIALS AS OTHERWISE THERE IS A RISK OF THERMAL INJURY TO THE PATIENT'S TISSUE, BURNS TO THE PATIENT'S OR USER'S SKIN OR BURNS OR THERMAL DAMAGE TO SURGICAL EQUIPMENT. THE USER FACILITY STAFF APPARENTLY DID NOT FOLLOW THESE INSTRUCTIONS AS THE PATIENT REPORTEDLY SUSTAINED A BURN ON THE SKIN AFTER THE TELESCOPE CONNECTOR OF THE LIGHT-GUIDE CABLE WAS PLACED ONTO THE MEDICAL DRAPE SHEET WHILE THE CONNECTED LIGHT SOURCE WAS SWITCHED ON. THEREFORE, THIS EVENT/INCIDENT WAS ATTRIBUTED TO ABNORMAL USE/OFF-LABEL USE AND THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS. HOWEVER, THE EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES AND THE USER WILL BE RETRAINED TO CORRECTLY USE THE OLYMPUS MEDICAL DEVICES.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AFTER AN UNSPECIFIED THERAPEUTIC SURGICAL PROCEDURE, IT WAS NOTICED THAT THE PATIENT HAD SUSTAINED A BURN OF APPROX. 1 CM IN SIZE ON THE SKIN. PRIOR TO THIS, THE USER FACILITY STAFF REPORTEDLY PLACED THE TELESCOPE CONNECTOR OF THE LIGHT-GUIDE CABLE FOR ABOUT SEVEN MINUTES ONTO THE MEDICAL DRAPE SHEET WHILE THE CONNECTED LIGHT SOURCE WAS SWITCHED ON. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO MALFUNCTION OF THE DEVICE. THE PATIENT WAS HOSPITALIZED AND SCHEDULED FOR AN APPOINTMENT WITH A DERMATOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231239 LIGHT GUIDE, SIZE S, PLUG TYPE, 3 M, CF TYPE LIGHT GUIDE AND ACCESSORIES EWY OLYMPUS WINTER & IBE GMBH WA03200A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R