MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; CATHETER GUIDE

Model Number	490107-07
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Upon inspection, it was observed that two pins were missing.One on the distal end and the other on the proximal end, which connect the sync arm links.One of the two pins came with the catheter guide, but the second pin was missing.No physical damages were found on the catheter guide, and no cracks were observed at the distal mount or crazing on the sync arm links.The pca board did not have any damages.The catheter guide was placed on the in-house system and passed initialization.The root cause of the missing pins is not established.
Event or Problem Description
It was reported that after an ion endobronchial lung biopsy procedure, the metal pin at the distal end of the catheter guide was missing.No issues experienced during the case.The diagnostic procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.
Additional Manufacturer Narrative
On 29-apr-2024, additional analysis investigation was completed: a visual inspection confirmed that two dowel pins were missing.The link holes at the location of the missing dowel pins were inspected.It was observed that the heat stake domes were not present at either location.Rma was reviewed with catheter guide manufacturing engineer.The heat stake domes not being present indicate that the manufacturing step to heat stake and the step to verify the heat stake were missed.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: CATHETER GUIDE
• 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: 19085749
• Report Number: 2955842-2024-13381
• Device Sequence Number: 15258025
• Product Code: EOQ
• UDI-Device Identifier: 00886874116289
• UDI-Public: (01)00886874116289(11)231116(10)S10231116
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 03/22/2024

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: 490107-07
• Device Catalogue Number: 490107
• Device Lot Number: S10231116 0142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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