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

Model Number	FPRPR3561
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to perform physical investigation.A needle manufacturing records could not be reviewed as the lot number was not provided by the customer.There was no alleged device malfunction so a device investigation was not conducted.Pain is a known complication of cryoablation procedures and is documented in the product labeling as potential adverse events.
Event or Problem Description
It was reported that shortly, after a nerve procedure was completed that patient experienced pain.One dose of morphine was given and the patient felt fine.The hospital technician thought the pain was due to hydro dissection.There was no alleged device malfunction.No other details provided suggest a more significant procedure related issue.

• Brand Name: ICESPHERE 1.5 S 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: 8429972
• Report Number: 9616793-2019-00019
• Device Sequence Number: 193438
• Product Code: GEH
• UDI-Device Identifier: 07290104830556
• UDI-Public: 07290104830556
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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: FPRPR3561
• Device Catalogue Number: FPRPR3561
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/18/2019
• 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