MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; VISION PROBE

Model Number	490206-01
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	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An isi did receive a da vinci product to perform failure analysis.The vision probe instrument was analyzed and failure analysis investigations did not replicate nor confirm the customer reported complaint.The functional test for the vision probe instrument could not be completely performed.An incomplete failure analysis occurred as the instrument had the shaft broken off which prevented proper use of the instrument.Additional observation was also identified: the vision probe instrument shaft was broken off.The broken piece was approximately 797mm x 2.1mm and not returned.Material was missing.The vision probe could still be installed on the connector plug of the ion system but as expected, initialization failures occurred because the vision probe was missing components for it to work.
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the vision probe instrument failed and had to be changed out.The diagnostic procedure was completed with no reported injury.An intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: no patient harm or impact what so ever.They had an issue when connecting the vision probe which seemed more of a connection issue.They unplugged and re plugged and could not get it to work.They used a backup to resolve the issue.

• Brand Name: ION
• Common Device Name: VISION PROBE
• 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: 18423069
• Report Number: 2955842-2023-21865
• Device Sequence Number: 7847091
• Product Code: EOQ
• UDI-Device Identifier: 00886874121184
• UDI-Public: (01)00886874121184(10)S14230914
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 12/14/2023

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: 490206-01
• Device Catalogue Number: 490206
• Device Lot Number: S14230914 0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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