MAUDE Adverse Event Report: GALIL MEDICAL LTD ICESPHERE 1.5 90 CRYOABLATION NEEDLE; CRYOABLATION NEEDLE, PRODUCT CODE

Model Number	FPRPR3560
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	10/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned and could not be investigated.The manufacturing records were reviewed and no related deviation or concerns were found.Vacuum sleeve failure is a known potential malfunction with some cryoablation needles.The risk to the patient is the potential for a skin burnt due to frost on the needle shaft.Galil medical's labeling includes precautions instructing users to protect the skin with warm saline, when appropriate.The case was completed with no patient injury.If additional information becomes available a followup report will be filed.
Event or Problem Description
It was reported that the doctor noticed the shaft of one of the icesphere needle started to collect frost.The procedure was completed as expected with no injury to the patient.

• Brand Name: ICESPHERE 1.5 90 CRYOABLATION NEEDLE
• Common Device Name: CRYOABLATION NEEDLE, PRODUCT CODE
• Manufacturer (Section D): GALIL MEDICAL LTD; 1 tavor building, p.o. box 224; industrial park; yokneam, israel 20692 03; IS 2069203
• MDR Report Key: 8036576
• Report Number: 9616793-2018-00070
• Device Sequence Number: 1379609
• Product Code: GEH
• UDI-Device Identifier: 07290104830945
• UDI-Public: 07290104830945
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2018

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: 11/01/2019
• Device Model Number: FPRPR3560
• Device Lot Number: A0473
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1