BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAMPING JAW, SMALL

    MDR report key: 16940967 · Received May 16, 2023

    Report

    Report Number
    9610617-2023-00079
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    February 27, 2023
    Report Date
    June 16, 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

    DURING THE INVESTIGATION OF THE CLAIMED ARTICLE, A BREAKAGE OF THE HOLDING ARM COULD BE DETECTED, WHICH IS PROBABLY DUE TO A REPROCESSING ERROR OR THE RESULTING CORROSION. DARK SPOTS ARE VISIBLE FROM WHERE THE CORROSION AND THE RESULTING WEAKENING OF THE MATERIAL COULD SPREAD. IN ADDITION, IMPURITIES ARE VISIBLE, WHICH PROBABLY CAUSED MICRO CRACKS. ACCORDING TO THE DATE OF MANUFACTURE (02.2018), THE ARTICLE IS 5 YEARS OLD, DURING WHICH TIME THE CRACKS WERE ABLE TO SPREAD AND FINALLY BREAK. THE IFU, THEREFORE, POINTS OUT THAT THE ARTICLES SHOULD BE CHECKED FOR DEFECTS AND DAMAGE BEFORE USE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 0

    THE ITEM IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    *THIS REPORT WAS INCORRECTLY FILED UNDER THE IMPORTER MFR NUMBER - 2020550-2023-00079. THE REPORT WAS FILED WITHIN THE FDA FILING TIMELINE. 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
    2183888 CLAMPING JAW, SMALL CLAMPING JAW OCV KARL STORZ SE & CO. KG 04048551265222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention