BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHIELDED ALPHAPROBE MICROELECTRODE

    MDR report key: 20703590 · Received November 18, 2024

    Report

    Report Number
    3001610756-2024-00002
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    August 30, 2024
    Report Date
    November 18, 2024
    Manufacturer
    ALPHA OMEGA ENGINEERING LTD
    Product Code
    GZL
    UDI-DI
    07290014954946
    PMA / PMN Number
    K120098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS NOT REPORTED TO ALPHA OMEGA ENGINEERING LTD. IN REAL TIME. OUR APPLICATION SPECIALIST, ALPHA OMEGA REP., WAS IN TOUCH WITH THE FACILITY. THE NEUROPROBE ALPHAPROBE WAS NOT SEND FOR MANUFACTURER EVALUATION, WE ASSUME IT WAS A MECHANICAL ISSUE, WE ASKED THE PROBE FOR FURTHER EVALUATION. THE FACILITY USED ALTERNATIVE PROBE DURING THE PROCEDURE.

    Description of Event or Problem · 0

    THE FACILITY REPORTER DESCRIBED THE EVENT AS FOLLOWS: "DESCRIBE THE EVENT OR PROBLEM: SUPPLY WAS TESTED BY SURGEON BEFORE USING IT ON PATIENT AND SUPPLY WAS FOUND TO BE "MANUFACTURED INCORRECTLY." WHAT WAS THE ORIGINAL INTENDED PROCEDURE? CRANIOTOMY, DEEP BRAIN STIMULATOR WITH MICROELECTRODE RECORDING, FIRST ARRAY. WHAT PROBLEM DID THE USER HAVE: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2611001 SHIELDED ALPHAPROBE MICROELECTRODE SHIELDED ALPHAPROBE MICROELECTRODE GZL ALPHA OMEGA ENGINEERING LTD STR-AP9080-00 87976 07290014954946

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown