MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ION; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	490105
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Two devices: (b)(6) 2022 upon reprocessing equipment, it was found to have a scratch or tear near the distal tip of articulating catheter, a discoloration was also noted internally around the area of defect.(s11220901 0013).(b)(6) 2022 possible fluid invasion, equipment did not pass pre-checks for procedure (s11220901 0016).

• Brand Name: ION
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 16303105
• Report Number: 16303105
• Device Sequence Number: 12460410
• Product Code: EOQ
• UDI-Device Identifier: 00886874116258
• UDI-Public: 00886874116258
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/24/2023
• Report Date (Section F): 01/24/2023

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
• Device Model Number: 490105
• Device Lot Number: S11220901 (0013 AND 0016)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/24/2023