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

Model Number	FPRCH6000
Medical Device Problem Codes	Insufficient Cooling (1130); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event- approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that there was insufficient ice caused by the console.A visual-ice cryoablation system was observed to only reach a temperature of 105 degrees, regardless of which needle or which channel is used.A needle was tested by the boston scientific representative as well, and the desired ice ball dimensions were not reached.There was no patient involvement.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17201501
• Report Number: 2124215-2023-32060
• Device Sequence Number: 12448052
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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: V50014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown