MAUDE Adverse Event Report: GALIL MEDICAL LTD. PRECISE CRYOABLATION SYSTEM; CRYOSURIGCAL DEVICES AND ACCESSORIES

Model Number FPRCH2047

Device Problems Device Displays Incorrect Message (2591); Failure to Fire (2610); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

A service engineer visited the system and was unable to duplicate the issue; the system worked fine when it was tested.The service engineer did note that the system logged a failure of the scardsvr service the previous day, which confirms why the user was unable to continue the procedure.However, the cause of the original 'communication with hardware' error was unable to be determined.The service engineer advised the customer not to use the system until the investigation and cause of the event has been determined.A follow-up report will be provided with the results of the investigation.

Event Description

During a cryoablation procedure, the screen on the presice system froze and we had to abandon a procedure.The user tested the needles and they were in the patient ready to begin the procedure.The screen on the system froze.The user tried to reboot the system and received a "communication hardware" error message on the screen which eventually disappeared, and a warning that the red emergency stop button was depressed (it wasn't).The system eventually allowed the user into the procedure screen but did not allow the procedure to be continued.The procedure was not completed and was abandoned.

• Brand Name: PRECISE CRYOABLATION SYSTEM
• Type of Device: CRYOSURIGCAL DEVICES AND ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; 1 tavor building, po box 224; industrial park; yokneam, 20692 03; IS 2069203
• Manufacturer (Section G): GALIL MEDICAL LTD.; 1 tavor building, po box 224; industrial park; yokneam, 20692 03; IS 2069203
• Manufacturer Contact: amy mckinney ; 1 tavor building, po box 224; industrial park; yokneam, 20692 ; IS 20692 ; 2875096
• MDR Report Key: 6530374
• MDR Text Key: 74052016
• Report Number: 9616793-2017-00018
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: FPRCH2047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: No
• 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