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	11/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported that the catheter would not pass the self-test after 6 tries.

• 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: 16014032
• Report Number: 16014032
• Device Sequence Number: 17977132
• 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): 11/18/2022
• Report Date (Section F): 11/18/2022

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
• Device Model Number: 490105
• Device Lot Number: S10220719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 12/20/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Race: White
• Date Report Sent to FDA: 11/18/2022