MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; CATHETER

Model Number	490105-21
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the fully articulating catheter was not engaging and was shredding.The customer was not sure if it was caused by the biopsy needle.The diagnostic procedure was completed with no reported injury.
Additional Manufacturer Narrative
The fully articulating catheter that was used in the procedure has been returned for failure analysis testing.However, the evaluation has not yet been completed as of the date of this report.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The fully articulating catheter was analyzed and the internal diameter of the catheter shaft was confirmed with damage while using a zibra vision probe as a visual aid.Damage indicated excessive friction, likely from a biopsy needle accidentally puncturing or scraping during installation or removal.Damage was located at the distal end of the shaft, approximately 67.1mm from the tip, evident by bubbling sensation when performing an internal diameter continuity test.Additionally, per the ifu reprocessing guidelines: a biomedical tester, saline bath, along with the proper ion reprocessing consumables were used for the continuity leak test.The catheter failed the continuity test.Leakage tester stated: leakage too high.Internal diameter continuity test: fail external diameter continuity test: pass additional note: air leak test passed.An in-house vision probe was also able to be installed and removed without issue through the catheter shaft.Logs showed that this catheter was used on (b)(6) 2024 using system en11 with no initialization errors.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.

• Brand Name: ION
• Common Device Name: CATHETER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 19149558
• Report Number: 2955842-2024-13722
• Device Sequence Number: 7406401
• Product Code: EOQ
• UDI-Device Identifier: 00886874116258
• UDI-Public: (01)00886874116258(11)240110(10)S15240110
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K212048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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: 490105-21
• Device Catalogue Number: 490105
• Device Lot Number: S15240110 0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ION ENDOLUMINAL SYSTEM.
• Patient Sex: Unknown