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

Model Number	470035-03
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the handheld camera head was observed to have a broken piece broken off and missing.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.Failure analysis found the primary finding of cable connector broken to be related to the customer reported complaint.The camera was found to have a broken cable connector.3 out of the 4 legs of the connector were broken off.As a result of the damage, the adaptor was also found to be broken, and the light guide adapter was completely dislodged from the connector.The light guide adapter was not returned with the camera.Due to the damage, the qap (quality assurance procedure) could not be performed on the in-house system.Functional tests were not performed.A review of logs showed five instances of error 48221 (communications error).The camera was found to have delamination.The distal bend protection was found delaminated from the camera housing.The camera was found to have cosmetic damage on the camera housing.Both sides of the camera housing were found to have no labeling.As a result, the label markings were illegible.The probable root cause is attributed to component susceptibility to damage during use.Damage can result from mishandling the instrument, such as collisions with other instruments or hard surfaces.
Additional Manufacturer Narrative
Intuitive followed up and obtained additional information.Customer had the piece that was broken off.It showed up.
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: 24600386
• Report Number: 2955842-2026-16230
• Device Sequence Number: 8365979
• Product Code: GCJ
• UDI-Device Identifier: 00886874115725
• UDI-Public: (01)00886874115725
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/08/2026

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: 03/02/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/14/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• 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