MAUDE Adverse Event Report: HEALTHTRONICS, INC. ENDOCARE CRYOCARE CRYOTHERAPY SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number CRYO-SL

Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

System tested by field service engineer(fse).Replaced electronics module (em), system retested in accordance with the manufacturers service manual.System is fully functional.Em assembly returned to healthtronics for evaluation.Device evaluated by simulated use testing, found non-specific electrical problem which caused the bios to fail.

Event Description

System set-up and pcs-24 probe pretested with no problems.Physician placed the probe and asked for it to be "stuck".When trying to activate, the software had completely locked up and was not responding.Powered off the system, moved the power plug to a different outlet, and attempted to reboot the system.System would boot.The green lights on the control pad blinked, but the monitor was completely blank.Powered off the system again and waited 90 seconds to power back on and received the same results.Called customer service and tried checking several things inside the system but nothing worked.It was then determined the machine was not useable and the physician removed the cryoprobe and cancelled the case.

• Brand Name: ENDOCARE CRYOCARE CRYOTHERAPY SYSTEM
• 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 Key: 5590840
• MDR Text Key: 44167235
• Report Number: 3008262715-2016-00012
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: CRYO-SL
• Device Lot Number: 8672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 58 YR