MAUDE Adverse Event Report: BTG ROUND LAKE ICEFX CRYOABLATION SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH8000
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was aborted.An icefx cryoablation system console was selected for use for this lung tumor cryoablation.During the procedure, there was a test failure on the console and the procedure was not able to be completed.
Event or Problem Description
It was reported that the procedure was aborted.An icefx cryoablation system console was selected for use for this lung tumor cryoablation.During the procedure, there was a test failure on the console and the procedure was not able to be completed.

• Brand Name: ICEFX 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14291030
• Report Number: 2134265-2022-05164
• Device Sequence Number: 1660144
• Product Code: GEH
• UDI-Device Identifier: 00859019006370
• UDI-Public: 00859019006370
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K181153
• 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,Followup
• Report Date (Section B): 06/01/2022

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 Model Number: FPRCH8000
• Device Catalogue Number: FPRCH8000
• Device Lot Number: IF0140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown