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

Model Number	380707-33
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.This unit was returned for failure analysis and reported/ repeated error code 41006 comes up when powering system up.Customer further installed catheter and got error code 32098.We visually inspected fim and installed on known good internal ion system.We then programmed to latest customer software and powered system on to normal mode.Right away upon starting up system triggered error code 41006.We then tried power cycling system 3 more time and every time tried error code 41006 occurred which looks as if printed circuit board issue.We have replicated problem at this and will continue to troubleshoot problem.
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the system experienced a 32098 recoverable fault when performing catheter tests.The esr noted that the arms were yellow, but they were unable to recover the fault.Prior to calling in the esr rebooted the system.Tse was on phone when the system powered on and esr reported a non-recoverable fault 41066.Tse completed all troubleshooting steps with no resolution.The site elected to abort the procedure to another ion at this time.The diagnostic procedure was converted to another ion with no reported injury.

• Brand Name: ION
• Common Device Name: CONTROLLER
• 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: 17015850
• Report Number: 2955842-2023-14976
• Device Sequence Number: 7565921
• Product Code: EOQ
• UDI-Device Identifier: 00886874116241
• UDI-Public: (01)00886874116241
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2022

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: 380707-33
• Device Catalogue Number: 380707
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• 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: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown