BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSORS, BLUNT, 5 FR., 34 CM

    MDR report key: 22680459 · Received July 31, 2025

    Report

    Report Number
    9610617-2025-01334
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Report Date
    July 31, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCJ
    UDI-DI
    04048551094280
    PMA / PMN Number
    K935071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCISSORS BREAK EVEN WHEN USED ONCE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE: MDR 25-1326, 25-1331, 25-1325, 25-1324 AND 25-1333.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2339379 SCISSORS, BLUNT, 5 FR., 34 CM SCISSORS, BLUNT, 5 FR., 34 CM GCJ KARL STORZ SE & CO. KG 26159EHW OK02 04048551094280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown