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 Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hepatic cryoablation procedure, an icesphere needle created frost down the shaft, possibly contacting the patient's skin.Two ten minute freeze cycles were completed prior, but the physician was not satisfied with the attained margin.The physician decided to reposition the first needle and add a second to obtain larger ice.The frost was noticed by the doctor at the end of the third freeze cycle.They dripped sterile saline at the insertion site and halted the freeze cycle.Sterile saline was then continuously dripped onto the needle shaft during freeze.The physician was satisfied at the attained margin using the two needles.No patient impact was reported.
Event or Problem Description
It was reported that during a hepatic cryoablation procedure, an icesphere needle created frost down the shaft, possibly contacting the patient's skin.Two ten minute freeze cycles were completed prior, but the physician was not satisfied with the attained margin.The physician decided to reposition the first needle and add a second to obtain larger ice.The frost was noticed by the doctor at the end of the third freeze cycle.They dripped sterile saline at the insertion site and halted the freeze cycle.Sterile saline was then continuously dripped onto the needle shaft during freeze.The physician was satisfied at the attained margin using the two needles.No patient impact was reported.
Additional Manufacturer Narrative
The device was returned for engineering analysis.The investigation testing results showed insufficient vacuum insulation of the sleeves resulting in the frost on the shaft.The needle was disassembled and no manufacturing issues were noted.No relationship was found between the needle's assembly processes and the vacuum loss phenomena identified.

• 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: 10168684
• Report Number: 2134265-2020-08217
• Device Sequence Number: 11291719
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 10/31/2021
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: T0349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2020
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1