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	Burn(s) (1757)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the needle shaft froze and a skin burn occurred.During a renal cryoablation procedure an icesphere 1.5 cx 90 degree needles was used.During freezing the needle shaft froze and required hot physiological serum to be used to avoid any further superficial burns.A new needle was used to complete the case.No further patient complications were reported.

• Brand Name: ICESPHERE 1.5 CX 90 DEGREE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; tavor bldng 1 industrial prk; po box 224; yokneam 20692 03; IS 2069203
• MDR Report Key: 10812138
• Report Number: 2134265-2020-15474
• Device Sequence Number: 4178053
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2022
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: U0298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention