BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIPCAM1 RUBINA 30°, OPAL1 NIR/ICG, 4K 3D

    MDR report key: 16380585 · Received February 15, 2023

    Report

    Report Number
    2020550-2023-00042
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    February 2, 2022
    Report Date
    February 15, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCJ
    UDI-DI
    04048551425688
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO KST THAT AFTER (ALMOST) 2 HOURS OF USE, THE HANDLE GETS VERY HOT AND A DOCTOR DEVELOPED A RED SPOT OF BURNED TISSUE AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126054 TIPCAM1 RUBINA 30°, OPAL1 NIR/ICG, 4K 3D RIGID VIDEO LAPAROSCOPE GCJ KARL STORZ SE & CO. KG 26606BCA 04048551425688

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other