MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICESPHERE 1.5 CX 90 DEGREE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3573
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was frost on the needle shaft.A cryoablation treatment procedure was performed using an icesphere 1.5 cx 90 degree cryoablation needle.Before insertion into the patient, the needles were tested and passed.A minute or two after starting the freeze cycle the needle insulation did not work.The physician protected the patient's skin with gauze and continuous irrigation.No patient injury was reported and the ablation zone indicated a likelihood of a successful outcome.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for engineering analysis and the complaint was confirmed.The needle shaft was returned bent.The shaft temperature of -17.9c points to insufficient thermal insulation of the needle.The needle was disassembled and found traces of soldering flux residuals and corrosive on the vacuum sleeve external and needle internal surfaces.No gas leaks were detected.There was no relationship found between the needles assembly processes and the vacuum loss phenomena.
Event or Problem Description
It was reported there was frost on the needle shaft.A cryoablation treatment procedure was performed using an icesphere 1.5 cx 90 degree cryoablation needle.Before insertion into the patient, the needles were tested and passed.A minute or two after starting the freeze cycle the needle insulation did not work.The physician protected the patient's skin with gauze and continuous irrigation.No patient injury was reported and the ablation zone indicated a likelihood of a successful outcome.

• Brand Name: ICESPHERE 1.5 CX 90 DEGREE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; tavor bldg 1 industrial park; po box 224; yokneam 20692 03; IS 2069203
• MDR Report Key: 10992596
• Report Number: 2134265-2020-17150
• Device Sequence Number: 14377383
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: 08/02/2021
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: A7103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 02/11/2021
• Patient Sequence Number: 1