MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; HANDHELD CAMERA HEAD

Model Number	470035-03
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the camera head; however, failure analysis is still ongoing.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the handheld camera head had a plastic piece broke off.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the sterile processing manager and obtained the following additional information: the customer clarified that the piece was broken off from the proximal end of the camera that does not enter the patient.The issue was identified prior to starting the procedure pre-anesthesia.The customer confirmed that the instrument was inspected prior to use and there was a piece of plastic broken off the distal end of the camera.No images or patient demographics available.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the handheld camera for failure analysis investigation.The instrument was analyzed and found to have a broken cable connector.The ic housing was found to have 2 out of 4 legs broken off, causing the light guided adapter to become detached but was returned with the camera.The light guide adapter was also found broken.As a result of the damage, the qa (quality assurance procedure) was unable to be performed and failed during setup.A review of logs showed qty 2 of 48221 communications error.Additional observations not reported by site: the camera cable was found to have cosmetic damage.The laser marking the housing was found to be partially removed from one side.The camera cable was found to have delamination on the distal bend protection.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: NONE
• 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: 22081380
• Report Number: 2955842-2025-21997
• Device Sequence Number: 9501534
• Product Code: GCJ
• UDI-Device Identifier: 00886874115725
• UDI-Public: (01)00886874115725
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K191043
• 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): 05/09/2025

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: 470035-03
• Device Catalogue Number: 470035
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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