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

Model Number CRYO-CS

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Information (3190)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation in process.

Event Description

Cryo-cs system had a critical error during the first freeze of the second procedure.Spent and hour on the phone with tech support before cancelling the case.

Manufacturer Narrative

Device was evaluated by simulated use testing and found memory component failure.Device was repaired and returned to the customer.

• 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: 6054014
• MDR Text Key: 58721802
• Report Number: 3008262715-2016-00037
• 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: distributor,health profession
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• 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-CS
• Device Lot Number: 06-0043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2006
• 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: 59 YR