MAUDE Adverse Event Report: MIRA, INC. MIRA CRYOSURGICAL CONSOLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	CR4000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During left eye vitrectomy, the circulating nurse and surgical tech attempted to set up the cryosurgery machine.The cryo probe initially was appearing not to work with either the left or right tank.Then when the probe did work properly and indicate that it was ready for use, the attending surgeon was readying to place it to the left eye when it began firing without anyone pushing the foot pedal.The unprompted firing made the attending decide to use another treatment option in place of the cryo which he had planned on using.This occurred once more at the end of the case when no one was near the cryo machine.

• Brand Name: MIRA CRYOSURGICAL CONSOLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): MIRA, INC.; 414 quaker hwy; uxbridge MA 01569
• MDR Report Key: 12405378
• Report Number: 12405378
• Device Sequence Number: 20116472
• Product Code: GEH
• UDI-Device Identifier: 10850510007467
• UDI-Public: (01)10850510007467
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/13/2021
• Report Date (Section F): 08/13/2021

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: CR4000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/13/2021