BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 8381761 · Received March 1, 2019

    Report

    Report Number
    2937094-2019-60275
    Event Type
    Injury
    Date Received
    March 1, 2019
    Date of Event
    December 18, 2018
    Report Date
    March 1, 2019
    Manufacturer
    MEDPLAST MEDICAL, INC.
    Product Code
    KNS
    PMA / PMN Number
    K180237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE WHILE THE PATIENT WAS SEDATED THE DELIVERY DEVICE NEEDLE WOULD NOT RETRACT CORRECTLY AND THE SYSTEM DISPLAYED ERRORS 240, 242, AND 465 AND COULD NOT COMPLETE SETUP. THE DELIVERY DEVICE WAS EXCHANGED AND THE SAME ISSUE WAS NOTED WITH THE SECOND DELIVERY DEVICE. THE CASE WAS CANCELED. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR THE SECOND DELIVERY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177096 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS MEDPLAST MEDICAL, INC. D2201 2018010004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other REZUM DELIVERY DEVICE (B)(4)| REZUM GENERATOR (B)(4)