BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2470515 · Received February 18, 2012

    Report

    Report Number
    9610617-2012-00006
    Event Type
    Other
    Date Received
    February 18, 2012
    Date of Event
    January 20, 2012
    Report Date
    February 17, 2012
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL IS NOT PLANNING TO RETURN THE DEVICE AT THIS TIME. PER HOSPITAL'S MANAGER OF BIOMEDICAL ENGINEERING THEY CONDUCTED THEIR OWN INVESTIGATION AND THEY FOUND AN UNFAMILIAR BATTERY IN THE DEVICE. HE SAID IT WAS EITHER A RECHARGEABLE BATTERY (THIS UNIT USES NON-RECHARGEABLE BATTERIES) OR A REGULAR BATTERY THAT WAS MISTAKENLY CHARGED BEFORE USE. HE SAID THE CAUSE OF THE DEVICE EXPLODING WAS INCORRECT BATTERY USAGE.

    Description of Event or Problem · 1

    ALLEGEDLY, THE DOCTOR WAS USING THE PORTABLE LIGHT TO LOOK AT A PATIENT WOUND IN THE FACIAL AREA; THE LIGHT SOURCE BURST OPEN AND EMITTED FLAMES. THE DOCTOR RECEIVED MINOR BURNS ON HIS NECK AND AN EYE ABRASION; THE PATIENT RECEIVED SOME MINOR BURNS ON HER EAR. BOTH THE DOCTOR AND THE PATIENT WERE TREATED WITH SILVADENE AND THEN BACITRACIN. THE DOCTOR SAID HIS AND PATIENT'S INJURIES ARE HEALING WELL. NO FURTHER MEDICAL TREATMENT WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ PORTABLE LIGHT SOURCE FCW KARL STORZ GMBH & CO. KG 11301D4 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other