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

Model Number CRYO-CS-3

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 12/11/2017

Event Type  malfunction  

Event Description

System operated normally until pretest.Upon pretesting of the first probe, the monitor indicated "i/o board error, system will terminate." rebooted the system 4 times but issue would not correct.Contacted service department.Case aborted.System brought to healthtronics for evaluation and repair.

Manufacturer Narrative

Device evaluated by simulated use testing and found possible vibration problem resulting in loss of communication with pcb.Device 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 dr.; building 3; austin TX 78717
• Manufacturer (Section G): HEALTHTRONICS, INC.; 9825 spectrum dr.; building 3; austin TX 78717
• Manufacturer Contact: deborah wilcoxen ; 9825 spectrum dr.; building 3; austin, TX 78717 ; 5124398334
• MDR Report Key: 7169682
• MDR Text Key: 96667922
• Report Number: 3008262715-2017-00053
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153489
• 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,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• 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-3
• Device Lot Number: 5630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2011
• 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: 65 YR