MAUDE Adverse Event Report: GALIL MEDICAL LTD. SEEDNET MRI CRYOABLATION SYSTEM; CRYOSURGICAL UNIT, ACCESSORIES

Model Number FPRCH2035

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 04/10/2015

Event Type  malfunction  

Event Description

During a cryoablation procedure, at the end of the second freezing cycle, the screen was not responding and the mouse pad did not respond.After 10 minutes of freezing, the technician shut the cylinder valve and turned off the computer with the key.The computer was turned on again and a message of "insert disk boot" appeared.The computer was turned on/off a few times and never booted up.Procedure was completed successfully.The computer (mri seednet) needs to be replaced.

Manufacturer Narrative

The system pc was returned to galil medical for investigation.The pc was connected to a seednet system.The pc booted up normally to the system s/w.The system general functionality check was performed and the pc functioned properly.The last procedure log files ((b)(6) 2015) were reviewed and the reported crash was identified.The windows log files were checked; no unusual findings were noted.A "scan disk" test was performed on the pc; no unusual findings were noted.It is suspected that the pc/windows crash is due to hard drive bad sectors which were not detected during the "scan disk" test.The pc was replaced and the system was returned to working order.The hard drive is an off-the-shelf item.

• Brand Name: SEEDNET MRI CRYOABLATION SYSTEM
• Type of Device: CRYOSURGICAL UNIT, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; yokneam ; IS
• Manufacturer (Section G): GALIL MEDICAL LTD.; yokneam gate, 1 tavor bldg.; yokneam 20692 ; IS 20692
• Manufacturer Contact: amy mckinney,vp ; 4364 round lake road; arden hills, MN 55112 ; 6512875096
• MDR Report Key: 4768531
• MDR Text Key: 5950093
• Report Number: 9616793-2015-00003
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• PMA/PMN Number: K021261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FPRCH2035
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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