BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 23262107 · Received October 9, 2025

    Report

    Report Number
    3000327445-2024-00001
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    February 6, 2024
    Report Date
    October 9, 2025
    Manufacturer
    PEGA MEDICAL INC
    Product Code
    FSM
    PMA / PMN Number
    K041393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OF FASSIER-DUVAL GUIDE WIRES FROM THE FD-CASE-4 INSTRUMENT TRAY HAD PROTRUDED THROUGH THE STERILISATION TIN AND INJURED FINGERS OF THE HOSPITAL STAFF. FROM THE IMAGES PROVIDED BY THE HOSPITAL IT CAN BE SEE THAT 3 FASSIER-DUVAL INSTRUMENT TRAYS WERE PACKED IN ONE BOX, THIS LED TO ONE SET TO BE PLACED IN A VERTICAL POSITION INSTEAD OF AN HORIZONTAL POSITION WHERE ALL THE INSTRUMENTS ARE SAFER TO HANDLE. AS A CONSEQUENCE, ONE OF THE SHARP G-WIRES FROM ONE OF THE TRAYS CAME OUT OF THE BOX AND THIS LED TO ONE OF HOSPITAL STAFF BEING INJURED. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR #3000327-2024-00001 ON FEBRUARY 27, 2024, BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (3000327445). CAPA INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    ONE OF FASSIER-DUVAL GUIDE WIRES FROM THE INSTRUMENT TRAY HAD PROTRUDED THROUGH THE STERILISATION TIN AND INJURED FINGERS OF THE HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029654 FASSIER-DUVAL TELESCOPIC IM SYSTEM EMPTY FD INSTRUMENT CASE - GENERATION IV FSM PEGA MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other