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

Model Number 490105

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2023

Event Type  malfunction  

Event Description

The catheter has a crack in the tip with fluid invasion.

• Brand Name: ION
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 17001622
• MDR Text Key: 315918328
• Report Number: 17001622
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 00886874116258
• UDI-Public: 00886874116258
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/18/2023

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 Catalogue Number: 490105
• Device Lot Number: S12230223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2023
• Date Report to Manufacturer: 05/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1