BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE, CRYOCARE, CRYOPROBE

    MDR report key: 2513196 · Received April 2, 2012

    Report

    Report Number
    3008262715-2012-00013
    Event Type
    Malfunction
    Date Received
    April 2, 2012
    Report Date
    July 6, 2012
    Manufacturer
    HEALTHTRONICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K011074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVENT OR PRODUCT INFORMATION PROVIDED. REPORTER STATED THAT PROBE IS TO BE RETURNED. REPEATED ATTEMPTS TO HAVE PROBE RETURNED AND TO GAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. IF PRODUCT IS RETURNED OR ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED

    Additional Manufacturer Narrative · 1

    FAILED TO PROVIDE 510K # ON FOLLOW-UP #1 K011074.

    Additional Manufacturer Narrative · 1

    MALFUNCTION OCCURRED DURING PRE-TESTING. NO PATIENT CONTACT OR INJURY REPORTED. DEVICE RECEIVED AND EVALUATION CONDUCTED. EVALUATION CONFIRMED THE REPORTED ISSUE OF SHAFT FROSTING. INVESTIGATION IDENTIFIED A VACUUM SLEEVE FAILURE.

    Description of Event or Problem · 1

    SHAFT FROSTED DURING PRETEST CYCLE.

    Description of Event or Problem · 1

    WHILE REPORTING A SHAFT FROSTING AE THAT OCCURRED ON (B)(6) 2012, THE PERSON MAKING THE REPORT STATED THAT THEY HAD ANOTHER PROBE THAT FAILED FOR SHAFT FROSTING. NO INFORMATION ON THIS AE WAS PROVIDED AT THE TIME OF REPORT. REPEATED ATTEMPTS TO GAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCARE, CRYOCARE, CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH HEALTHTRONICS, INC. PERC-24-L 3940

    Patients

    Seq Age Sex Outcome Treatment
    1