MAUDE Adverse Event Report: GALIL MEDICAL LTD ICEFORCE¿ 2.1 CX L 90° NEEDLE; CRYOABLATION NEEDLE

Model Number	FPRPR3618
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
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 shafts temperature is 2°c which points to insufficient thermal insulation of the needle; however the ice ball size is within the specification and was not compromised due to thermal insulation loss.Needle disassembly did not find any visible soldering gaps or voids nor corrosive signs or soldering flux residual.Based on the investigation results, the root cause determined insufficient vacuum insulation of the needle; however there was no relationship found between the needle manufacturing process and the vacuum loss phenomena.The treatment was completed with no injury to the patient.Galil medical's labeling includes precautions instructing users to protect the skin with warm saline, when appropriate.
Event or Problem Description
It was reported that during the freeze cycle of a cryoablation procedure, frost collected on the shaft of the needle.The patient's skin was protected and the case was completed with no injury to the patient.The needle was returned for investigation.

• Brand Name: ICEFORCE¿ 2.1 CX L 90° NEEDLE
• 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: 8932681
• Report Number: 9616793-2019-00051
• Device Sequence Number: 13513678
• Product Code: GEH
• UDI-Device Identifier: 07290104831089
• UDI-Public: 07290104831089
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162599
• 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
• Report Date (Section B): 08/26/2019

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: Health Professional
• Device Expiration Date: 08/16/2020
• Device Model Number: FPRPR3618
• Device Catalogue Number: FPRPR3618
• Device Lot Number: A1046-005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1