BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIVERTICULOSCOPE - WEERDA

    MDR report key: 6041591 · Received October 19, 2016

    Report

    Report Number
    9610617-2016-00156
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    August 9, 2016
    Report Date
    September 20, 2016
    Manufacturer
    KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
    Product Code
    EOQ
    PMA / PMN Number
    K953596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    WE RECEIVED A COPY OF AN MDR (MW5064384) FROM THE FDA; THE MDR REPORT DID NOT PROVIDE HOSPITAL NAME OR CONTACT NAME AND NUMBER, THUS WE WERE UNABLE TO CONDUCT MEDICAL EVENT FOLLOW UP OR ARRANGE FOR INSTRUMENT TO RETURN FOR EVALUATION. WE ARE FILING THIS MDR BASED SOLELY ON THE INFORMATION CONTAINED IN THE MDR FROM THE FDA; NO OTHER INFORMATION IS AVAILABLE. HERE IS TEXT: ALLEGEDLY, "IT WAS NOTICED DURING THE PROCEDURE THAT THE SKIN ON THE PT'S NOSE WAS REDDENED. AT THIS POINT, WET GAUZE WAS PLACED BETWEEN THE LIGHT CARRIER AND THE PT'S SKIN, BUT NOT BEFORE THE PT SUSTAINED A SUPERFICIAL BURN TO NOSE FROM LIGHT CARRIER OVERHEATING. IT APPEARS THAT THE SCOPE WAS FUNCTIONING PROPERLY, UNCLEAR WHY LIGHT SOURCE GENERATED ENOUGH HEAT TO CAUSE A SUNBURN EFFECT - COOL COMPRESS APPLIED THEN BACITRACIN OINTMENT TO NOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692964 DIVERTICULOSCOPE - WEERDA DIVERTICULOSCOPE EOQ KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 12067A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other