BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS CRYOMAZE 10-S PROBE

    MDR report key: 2083279 · Received April 27, 2011

    Report

    Report Number
    2083279
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ATS MEDICAL
    Product Code
    OCL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PROBE TEMPERATURE WENT TO -105 DEGREES. IT SHOULD HAVE BEEN MAINTAINED AT -150 DEGREES. THE SURGEON HAD BENT THE FLEXIBLE TIP OF PROBE AT SOLDERED JOINT. THE SALES REP SAID THE PROBE SHOULD BE BENT 1 TO 2 INCHES FROM SOLDERED JOINT. THE SURGEON SAID WHEN HE WAS IN-SERVICE ON THE PROBE, HE WAS NEVER TOLD OF ANY RESTRICTIONS AS TO WHERE TIP COULD BE BENT.====================== MANUFACTURER RESPONSE FOR SURGICAL ABLATION PROBE, ATS CRYOMAZE 10-S PROBE (PER SITE REPORTER)======================THE SALES REP SAYS THE PROBE SHOULD NOT HAVE BEEN BENT AT SOLDERED JOINT. THERE HAVE BEEN OTHER REPORTED PROBLEMS WHEN TIP HAS BEEN BENT AT SOLDERED JOINT. THEY ARE GOING TO REPLACE THE PROBE. THEY WANT TO EVALUATE THE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS CRYOMAZE 10-S PROBE PROBE, ABLATION, CRYO, CARDIAC OCL ATS MEDICAL 60SF3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR