BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANADY HYBRID PLASMA SCALPEL (HANDLE+35MM TIP)

    MDR report key: 14084603 · Received April 11, 2022

    Report

    Report Number
    MW5108899
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    March 28, 2022
    Report Date
    March 28, 2022
    Manufacturer
    US MEDICAL INNOVATIONS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TIP OF CANADY HAND PIECE CAME OFF DURING THE CASE. THIS IS THE 4TH CANADY HANDPIECE WITH THIS ISSUE IN THE LAST 4 WEEKS. COMPANY WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788468 CANADY HYBRID PLASMA SCALPEL (HANDLE+35MM TIP) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI US MEDICAL INNOVATIONS 0007-5554-22
    788469 CANADY HYBRID PLASMA SCALPEL (HANDLE+35MM TIP) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI US MEDICAL INNOVATIONS
    788470 CANADY HYBRID PLASMA SCALPEL (HANDLE+35MM TIP) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI US MEDICAL INNOVATIONS
    788471 CANADY HYBRID PLASMA SCALPEL (HANDLE+35MM TIP) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI US MEDICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male