MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI; HANDHELD CAMERA HEAD

Model Number	470035-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure the white connector was pulled out regarding the handheld camera.The procedure was converted to open surgery.Intuitive surgical, inc.(isi) followed up with the customer and gathered the following information: the customer was unsure why the procedure was converted to open surgery.The issue was discovered at the end of the day.The procedure was completed with no indication of patient injury.
Additional Manufacturer Narrative
A return material authorization (rma) was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope was analyzed and found to have a broken cable connector.The light guide adapter was found completely broken off from the connector.The adapter was returned but both retaining springs, release lever and the return spring of the release lever were not returned.The testing was performed and passed during the focus test; all images and targets had no issue.A log review confirmed but did not replicate the errors 48221 and promoting camera communication error 48225 camera power failure 48229 -camera power warning 45310 loss of image in both eyes, and 48215 camera error sensor start failure 48406 watchdog illuminator timeout.Additional findings not related to the customer reported complaint: the camera cable was found to have cosmetic damage.The laser markings on the housing were found partially removed on both sides.The camera cable was found to have delamination on the distal bend protection.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Correction to update instrument information to reflect reported complaint.

• Brand Name: DA VINCI XI
• Common Device Name: HANDHELD CAMERA HEAD
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20348926
• Report Number: 2955842-2024-20030
• Device Sequence Number: 8024058
• Product Code: NAY
• UDI-Device Identifier: 00886874115725
• UDI-Public: (01)00886874115725
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• 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,Followup
• Report Date (Section B): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470035-02
• Device Catalogue Number: 470035
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/05/2024; 11/05/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/21/2024; 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2016
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose