MAUDE Adverse Event Report: BTG YOKNEAM 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported frost on the shaft of the needle occurred.During treatment of a fibrous dysplasia mass of the femur, two icesphere 1.5 cx 90 degree cryoablation needles were used.Ice was seen on the needle shaft of one of the icesphere needles.The patient skin was protected during the case to prevent skin ulceration.The procedure was completed without patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for engineering analysis.The device was connected to the console and a freeze test was ran.During the freeze test the needle temperature was below specifications and indicates an insulation deficiency.The device was disassembled for further testing.Under microscopic inspection there were no visible soldering gaps or voids found when looking at the joint to shaft soldering.Under microscopic inspection there was also no evidence of soldering flux residuals or corrosive signs on the vacuum sleeve's external surfaces.A vacuum sleeve insulation test was performed and showed ice forming on the entire sleeve.This indicates insufficient thermal insulation of the needle and confirms the sites complaint of frost on shaft.
Event or Problem Description
It was reported frost on the shaft of the needle occurred.During treatment of a fibrous dysplasia mass of the femur, two icesphere 1.5 cx 90 degree cryoablation needles were used.Ice was seen on the needle shaft of one of the icesphere needles.The patient skin was protected during the case to prevent skin ulceration.The procedure was completed without patient complications.

• Brand Name: ICESPHERE 1.5 CX 90 DEGREE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): GALIL MEDICAL LTD.; tavor bldg 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13417139
• Report Number: 2134265-2022-00980
• Device Sequence Number: 3872015
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/16/2022

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: 08/03/2023
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: U3389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown