MAUDE Adverse Event Report: BTG ROUND LAKE VISUAL-ICE CRYOABLATION SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH6000
Medical Device Problem Codes	Mechanical Problem (1384); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the procedure was canceled due to a fault in the cryoablation systems.A visual-ice cryoablation system was selected for a renal cryoablation procedure.During the procedure set-up, the needles were inserted, and one of the channels did not log any needles.The needles were moved to a new channel, but the screen greyed out and no buttons could be pressed.The visual-ice cryoablation system was exchanged for a second visual-ice cryoablation system, and the needles were also exchanged for new ones.However, the same faults occurred with the new console and needles.The procedure was rescheduled to a later date as a result.The patient was sedated under general anesthesia at the time of the procedure cancellation.There were no complications reported.

• Brand Name: VISUAL-ICE CRYOABLATION SYSTEM
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG ROUND LAKE; 4364 round lake road; arden hills MN 55112
• Manufacturer (Section G): GALIL MEDICAL; 4364 round lake road; arden hills MN 55112
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16255154
• Report Number: 2124215-2023-02409
• Device Sequence Number: 14790118
• Product Code: GEH
• UDI-Device Identifier: 00867379000006
• UDI-Public: 00867379000006
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2023

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 Model Number: FPRCH6000
• Device Catalogue Number: FPRCH6000
• Device Lot Number: VL0318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown