MAUDE Adverse Event Report: GALIL MEDICAL LTD ICESPHERE 1.5 90 CRYOABLATION NEEDLE

Model Number	FPRPR3560
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During a perc renal procedure an issue with icesphere plus needle was observed.The doctor noticed the shaft of the icesphere needle started to collect frost.The patient's skin was covered with saline to prevent frostbite.The procedure was completed as expected with no injury to the patient.
Additional Manufacturer Narrative
The needle was returned for investigation.The manufacturing records were reviewed and no related deviation or concerns were found.The reported frost on the needle shaft was confirmed as the needle failed investigative testing.The needle was disassembled and inspected.No visible soldering gaps or voids were not found.Microscopic inspection identified solder flux on the surface of the sleeve.A bubble test of the vacuum sleeve was conducted; no leaks were identified.Based on the investigation results, the customer complaint was verified and the root cause was determined to be a component failure.No relationship was identified between the needle assembly processes and the vacuum loss phenomena.There was no injury to the patient.

• Brand Name: ICESPHERE 1.5 90 CRYOABLATION NEEDLE
• Common Device Name: CRYOABLATION NEEDLE
• Manufacturer (Section D): GALIL MEDICAL LTD; 1 tavor building, p.o. box 224; industrial park; yokneam,, israel 20692 ; IS 20692
• MDR Report Key: 6606488
• Report Number: 9616793-2017-00031
• Device Sequence Number: 10914114
• Product Code: GEH
• UDI-Device Identifier: 07290104830945
• UDI-Public: 07290104830945
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K141485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: FPRPR3560
• Device Lot Number: B8920-032
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1