BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAMPING JAW, SMALL

    MDR report key: 16747120 · Received April 14, 2023

    Report

    Report Number
    2020550-2023-00079
    Event Type
    Injury
    Date Received
    April 14, 2023
    Date of Event
    February 27, 2023
    Report Date
    April 14, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    OCV
    UDI-DI
    04048551265222
    PMA / PMN Number
    K990334
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    DURING THE NEUROSURGICAL INTERVENTION OF COLLOID CYST EXCISION BY VENTRICULAR ENDOSCOPY, THE ENDOSCOPE IS HELD BY A METAL ARM FIXED TO THE INTERVENTION TABLE IN ORDER TO FREE THE SURGEON'S HAND. AT THE END OF THE OPERATION, THE CLAMPING JAW USED TO HOLD THE ENDOSCOPE BROKE, CAUSING MOVEMENT OF THE ENDOSCOPE WHICH WAS IN THE PATIENT'S BRAIN, CAUSING BLEEDING FROM THE EPENDYMAL VEINS AND REDUCING VISIBILITY FOR THE END. INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739394 CLAMPING JAW, SMALL CLAMPING JAW OCV KARL STORZ SE & CO. KG 04048551265222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention