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	Burn, Thermal (2530)
Date of Event	11/04/2017
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 needle was disassembled and inspected.No visible soldering gaps or voids were found.Microscopic inspection of the vacuum sleeve was conducted and no corrosive pits or soldering flux residuals were identified on the external surface of the vacuum sleeve.A bubble test of the vacuum sleeve was conducted; no leaks were identified.Based on the investigation results, the customer complaint was verified and the root cause was determined to be a component failure.No relationship was identified between the needle assembly processes and the vacuum loss phenomena.The treatment was completed with no injury to the patient as the physician used continuous warm saline and subcutaneous infiltration to protect the patient's skin.Mdr for the second needle was submitted under mfr # 9616793-2017-00119.
Event or Problem Description
Prior to a rectus abdominus desmoid tumorcryoablation procedure, four icerod plus 90° needles and system tested fine with no issues to report.The physician was focused on hydro-dissection of the bowel and observing the intraprocedural iceball growth and did not realize the shafts of two of the needles started to collect frost.When he noticed the frosting, the skin around the needle insertion sites was purple and hard, presenting with a typical appearance of freezing and lack of perfusion.He attempted to inject warm saline subcutaneously, but the skin was too hard.Warm saline was therefore applied to the skin.The procedure was completed successfully and does not plan on additional procedures.No injury was observed post-procedurally.The patient returned for a 10-day postop appointment and the physician noted that the wound to be approximately 1 cm in length.During the 10-day post-procedure period, no wound care measures were taken.Patient has recovered with no sequelae.

• 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: 6994303
• Report Number: 9616793-2017-00118
• Device Sequence Number: 1293006
• Product Code: GEH
• UDI-Device Identifier: 07290104830563
• UDI-Public: 07290104830563
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K110946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 11/01/2017

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: 05/29/2017
• Device Model Number: FPRPR3508
• Device Lot Number: B8908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1