BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSORS, POINTED, 5 FR., 34 CM

    MDR report key: 22709228 · Received August 4, 2025

    Report

    Report Number
    9610617-2025-01335
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 4, 2025
    Report Date
    August 4, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GJC
    UDI-DI
    04048551094471
    PMA / PMN Number
    K935071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE 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

    ACCORDING TO THE INFORMATION RECEIVED JAW OF SCISSOR BROKE OFF DURING HYSTEROSCOPIC PROCEDURE FOR ADHESIOLYSIS AND POLYP REMOVAL LEAVING A PART OF THE SCISSOR BLADE IN THE PATIENTS UTERUS. THE DISLODGED PART WAS ABLE TO BE FLUSHED OUT OF THE PATIENT AND RECOVERED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2633934 SCISSORS, POINTED, 5 FR., 34 CM SCISSORS, POINTED, 5 FR., 34 CM GJC KARL STORZ SE & CO. KG 26159SHW RP02 04048551094471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown