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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEALTHTRONICS, INC. ENDOCARE CRYOCARE CRYOPROBE; UNIT, CRYOSURGICAL, ACCESSORIES
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HEALTHTRONICS, INC. ENDOCARE CRYOCARE CRYOPROBE; UNIT, CRYOSURGICAL, ACCESSORIES Back to Search Results
Model Number PCS-17R
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2016
Event Type  malfunction  
Manufacturer Narrative
Functional testing confirmed the reported issue.Probe disassembly and evaluation per internal procedures showed that a vacuum sleeve failure was the cause of the frosting.Attempts to gain patient information have been unsuccessful.
 
Event Description
Probe froze up the shaft during the procedure.Tried another probe.
 
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Brand Name
ENDOCARE CRYOCARE CRYOPROBE
Type of Device
UNIT, CRYOSURGICAL, ACCESSORIES
Manufacturer (Section D)
HEALTHTRONICS, INC.
9825 spectrum drive
building 3
austin TX 78717
Manufacturer (Section G)
HEALTHTRONICS, INC.
9825 spectrum drive
building 3
austin TX 78717
Manufacturer Contact
deborah wilcoxen
9825 spectrum drive
building 3
austin, TX 78717
5124398334
MDR Report Key5780598
MDR Text Key49844482
Report Number3008262715-2016-00023
Device Sequence Number1
Product Code GEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101333
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date01/12/2019
Device Model NumberPCS-17R
Device Lot Number19184
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received06/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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