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

Model Number FPRCH2035

Device Problems Partial Blockage (1065); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2016

Event Type  malfunction  

Event Description

During an mri guided cryoablation procedure, during the second freezing cycle, needles on group 2 and 4 stopped freezing after 2 minutes.These needles were relocated on another groups (1 and 3), but after a few minutes, the ice did not seem to extend on the mr images.The second cycle was shortened because the needles did not seem to freeze correctly.The procedure was then aborted.

Manufacturer Narrative

Corrected data: unchecked life threatening (previously mistakenly checked).The system was visited by a field service engineer and the internal dryers were replaced.The dryers were returned to galil medical and one of the 5cc dryers was found to be out of specification.Much of the desiccant material in the dryer was found to be granulated into powder form.The issue was discussed with the vendor of the dryers and a corrective action was implemented in (b)(6) 2015.The dryers in this system were manufactured prior to the implementation of this corrective action.There was no injury to the patient.

Event Description

During an mri guided cryoablation procedure, during the second freezing cycle, needles on group 2 and 4 stopped freezing after 2 minutes.These needles were relocated on another groups (1 and 3), but after a few minutes the ice did not seem to extend on the mr images.The second cycle was shortened because the needles did not seem to freeze correctly.The procedure was then aborted.

• Brand Name: MRI SEEDNET GOLD SYSTEM
• Type of Device: CRYOSURGICAL UNIT 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: 5444724
• MDR Text Key: 39000228
• Report Number: 9616793-2016-00002
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K993965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FPRCH2035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• 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
• Patient Outcome(s): Life Threatening