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

Model Number	FPRPR3573
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The procedure was related to the (b)(6) clinical study.It was reported that there was a gas/air leak from the needle shaft.An icesphere 1.5 cx 90 degree cryoablation needle was selected for a cancer treatment cryoablation procedure.When the needle was removed from packaging for testing, a darkened spot on the needle cover was observed.When the device was tested, and the gas phase hit, the needle immediately started bubbling; a gas/air leak was noted at the needle shaft.It seemed to line up with where the darkened mark was on the cover.The procedure was completed using another of the same device.No patient complications were reported.
Event or Problem Description
The procedure was related to the abscopal effect clinical study.It was reported that there was a gas/air leak from the needle shaft.An icesphere 1.5 cx 90 degree cryoablation needle was selected for a cancer treatment cryoablation procedure.When the needle was removed from packaging for testing, a darkened spot on the needle cover was observed.When the device was tested, and the gas phase hit, the needle immediately started bubbling; a gas/air leak was noted at the needle shaft.It seemed to line up with where the darkened mark was on the cover.The procedure was completed using another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the needle was returned for engineering analysis and the complaint of a gas leak in the needle shaft was confirmed.Needle disassembly found solder flux and corrosion were on the vacuum sleeve.The vacuum sleeve did not lose vacuum.Borescope inspection found signs of solder flux inside the needle shaft.

• 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
• Manufacturer (Section G): GALIL ISRAEL; tavor bldg 1; yoenaem 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12387952
• Report Number: 2134265-2021-10911
• Device Sequence Number: 11924449
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: 01/25/2022
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: U0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White