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

Model Number	490105-11
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, when the vision probe was put through the catheter guide, there was a yellow ring and the customer was unable to visualize to move forward with the procedure.The customer performed multiple attempts to try to get the catheter guide to work until switching to a new one.The diagnostic procedure was completed with no reported injury.
Additional Manufacturer Narrative
Based on the claim against the product noting physical damage, an investigation is completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The catheter was analyzed and failure analysis investigations confirmed the customer reported complaint.Upon failure analysis, the gold plated tip ring at the distal end of the shaft appeared to have broken off.Material was missing, approximately 0.08" x 0.03" in size, and was not returned by the customer.
Additional Manufacturer Narrative
This instrument was further evaluated, and the following additional information was obtained: the catheter tip ring was observed to be missing.The catheter showed deformation of the tip and visible cracks on the solder.The cracked solder was most likely due to the damaged tip.The root cause of the damaged tip is likely an excessive external load applied at the tip.The instrument was also evaluated by an ion catheter design engineer with the following findings: due to ovalization of the catheter tip, the solder joint is compromised and led to tip ring dislodgement.

• 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: 17122881
• Report Number: 2955842-2023-16294
• Device Sequence Number: 15067382
• Product Code: EOQ
• UDI-Device Identifier: 00886874116258
• UDI-Public: (01)00886874116258(10)S10230216
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K182188
• 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): 05/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: 490105-11
• Device Catalogue Number: 490105
• Device Lot Number: S10230216 0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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