MAUDE Adverse Event Report: GALIL MEDICAL LTD ICEROD 1.5 MM 90 MRI NEEDLE / MRI SE; CRYOABLATION NEEDLE

Model Number	FPRPR3195
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information was reported that following a liver cryoablation procedure with an icerod mri needle, it was noticed that the patient had a heat skin burn.Information regarding treatment or intervention was not provided.The needle will be returned for investigation.
Additional Manufacturer Narrative
The needle was not returned to galil medical for evaluation.The user facility conducted in-house testing of the complaint related needle and results were shared and analyzed by galil medical.Galil's investigation summary of the analysis determined that the reported skin burn was due to inclusion of a sheath over the mri needle and mcp connection (mobile connection panel) during the mri scan, which caused heating above the values stated in the product labeling.The sheath is not provided by galil medical and the product labeling does not include instruction for use of a sheath in the ifu or user manual.Galil medical's ifu does warn that potential adverse events can include skin burn.There have been no previous reports or complaints received for such an event associated with this needle type.This event is attributed to the off-label use of an external component (sheath).A capa investigation was initiated to assess if further actions are required.
Event or Problem Description
This is a follow up #1 to report investigation findings.As reported in the initial: limited information was reported that following a liver cryoablation procedure with an icerod mri needle, it was noticed that the patient had a heat skin burn.Information regarding treatment or intervention was not provided.The needle will be returned for investigation.

• Brand Name: ICEROD 1.5 MM 90 MRI NEEDLE / MRI SE
• Common Device Name: CRYOABLATION NEEDLE
• Manufacturer (Section D): GALIL MEDICAL LTD; 1 tavor building; p.o. box 224; industrial park, 20692 03; IS 2069203
• MDR Report Key: 9266838
• Report Number: 9616793-2019-00074
• Device Sequence Number: 2132355
• Product Code: GEH
• UDI-Device Identifier: 07290104830297
• UDI-Public: 07290104830297
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K051052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FPRPR3195
• Device Catalogue Number: FPRPR3195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other