BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOPROBE D2.4 MM/13G, 134 MM, TROCAR, ELLIPTIC

    MDR report key: 17109940 · Received June 12, 2023

    Report

    Report Number
    3008797959-2019-00002
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    August 30, 2019
    Report Date
    September 26, 2019
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K102360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED BY THE USER. THE INVESTIGATION WAS BASED ON THE COMPLAINT DESCRIPTION.

    Description of Event or Problem · 0

    *FROM ABUNDANCE OF CAUTION AFTER A REVIEW OF THE MAUDE DATABASE DID NOT FIND THE ORIGINAL REPORT SUBMITTED ON (B)(6) 2019, IT WAS DECIDED TO RESUBMIT THE ORIGINAL MDR. A CRYOPROBE BENT WHILE INTRODUCED INTO A BREAST TISSUE. "DR. (B)(6) WAS USING A 2.4L PROBE AND PUTTING A LOT OF PRESSURE ON THE NEEDLE TO THE POINT WHERE HE BENT IT, THE USER KNEW HE COULD NOT PROCEED WITH THE BENT NEEDLE THEREFORE IT WAS DECIDED TO BE REPLACED. HE TOOK THE NEEDLE OUT OF THE BREAST AND HOLD THE HANDLE IN HIS HAND WITH THE NEEDLE POINTING STRAIGHT UP. HE DID NOT ATTEMPT TO DISENGAGE THE NEEDLE B/C HE KNEW IT NEEDED TO DEPRESSURIZE. THE USER HIT CANCEL ON THE MACHINE AND THE EXTERIOR SHELL OF THE NEEDLE DISCONNECTED AND STUCK IN THE CEILING". THE CRYOPROBE WAS SUCCESSFULLY REMOVED PER STANDARD PROCEDURE AND WAS REPLACED. DURING THE REPLACEMENT, WHEN OUTSIDE OF THE BODY, THE USER PRESS CANCEL ON THE MACHINE AND THE WELDING THAT CONNECT THE PROBE INTERNAL PART TO THE EXTERNAL SHAFT BROKE AND THE EXTERNAL SHAFT DISCONNECT FROM THE PROBE. THE PROCEDURE WAS STOPPED DURING THE REPLACEMENT AND A NEW PROBE WAS CONNECTED TO THE SYSTEM TO FINISH THE PROCEDURE AS PER STANDARD PROCEDURE. THE PHYSICIAN REPORTS THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PROBE WAS DISCARDED FOLLOWING HOSPITAL STANDARD PROCEDURE AND WAS NOT SENT FOR ANALYSIS TO ICECURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606771 CRYOPROBE D2.4 MM/13G, 134 MM, TROCAR, ELLIPTIC CRYOPROBE GEH ICECURE MEDICAL LTD. FAP7800000 20180724A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other