MAUDE Adverse Event Report: HEALTHTRONICS, INC. ENDOCARE CRYOCARE CRYOTHERAPY SYSTEM T-2000 W/O WARMER; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number CRYO-CS

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

Machine turned on and booted-up.While in patient information screen, following short delay, system locked up.Shut system down and rebooted.Got blue screen and error message.Tried several times to re-boot with the same results.Called service, went through several trouble shooting steps before deciding to use the external hard drive.Once external hd connected, able to boot system up and complete this case as well as the following case as intended.Patient anesthesia time extended 55 minutes.

Manufacturer Narrative

Investigation in process.

Manufacturer Narrative

Field service engineer (fse) confirmed issue.System failed to recognize hard disk drive (hdd).Back-up hard drive used to treat cases.Fse replaced hdd and ide interface cable.System tested in accordance with manufacturers service manual and is fully operational.Original hdd returned to healthtronics for further evaluation.Image found to be bad.This is a known issue with windows based software environment that occasionally becomes corrupt.

• Brand Name: ENDOCARE CRYOCARE CRYOTHERAPY SYSTEM T-2000 W/O WARMER
• 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: 4662404
• MDR Text Key: 5729874
• Report Number: 3008262715-2015-00006
• 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: Health Professional,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• 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-CS
• Device Lot Number: 06-0217
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2006
• 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: 66 YR