BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARUS LASE

    MDR report key: 396432 · Received May 16, 2002

    Report

    Report Number
    2183911-2002-00002
    Event Type
    Other
    Date Received
    May 16, 2002
    Report Date
    May 13, 2002
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED TO CLARUS MEDICAL ON MAY 8,2002 THAT THE TIP OF TWO LASE ENDOSCOPES WERE LEFT IN A PATIENT. THE LOCATION OF THE TIPS AFTER SURGERY WAS THE NUCLEUS INSIDE OF THE SPINAL DISC. THE EXACT LEVEL IS UNKNOWN BY THE MANUFACTURER. NO PATIENT INJURY WAS REPORTED TO THE MANUFACTURER. THE TIP MATERIAL IS BIOCOMPUTIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARUS LASE ENDOSCOPIC DISCECTOMY DEVICE GEX CLARUS MEDICAL, LLC. 1100-002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other