BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANADY HYBRID PLASMA SCALPEL

    MDR report key: 18346283 · Received December 15, 2023

    Report

    Report Number
    MW5149317
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 29, 2023
    Report Date
    December 13, 2023
    Manufacturer
    US MEDICAL INNOVATIONS LLC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING TOTAL HIP ARTHROPLASTY PROCEDURE, SURGEON NOTICED THAT THE TIP OF THE CANADY HYBRID PLASMA SCALPEL BROKE OFF. STAFF WERE UNABLE TO LOCATE THE BROKEN PIECE OF TIP. X-RAY WAS DONE TO CONFIRM THAT BROKEN TIP WAS NOT IN WOUND BED OR ANYWHERE ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59413 CANADY HYBRID PLASMA SCALPEL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI US MEDICAL INNOVATIONS LLC. AW-422554 0094--S554-23

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown