MAUDE Adverse Event Report: GALIL MEDICAL LTD ICEROD PLUS 90° NEEDLE; CRYOABLATION NEEDLE

Model Number	FPRPR3508
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2017
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 burn 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.Mdr for the second needle was submitted under mfr # 9616793-2017-00114.
Event or Problem Description
The customer reported that the doctor noticed the shafts of 2 of the icerod plus 90° needles started to collect frost.The patient's skin was protected to prevent any injury.The procedure was completed as expected with no injury to the patient.

• Brand Name: ICEROD PLUS 90° 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: 6899322
• Report Number: 9616793-2017-00113
• Device Sequence Number: 761725
• Product Code: GEH
• UDI-Device Identifier: 07290104830563
• UDI-Public: 07290104830563
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2017

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: 07/24/2018
• Device Model Number: FPRPR3508
• Device Lot Number: B9076-014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1