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

Model Number	470042-03
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted inguinal hernia procedure, the nurse sustained a burn to their hand while removing the 5mm da vinci camera light guide cord from the endoscopic controller.The light guide cord was plugged into the endoscopic controller on the system and then attached to a third-party endoscope and laparoscope.The metal end of the light guide cord was very hot while attempting to be removed.The nurse's hand was red; no burn was produced.No further intervention was required to address the burn; the nurse did not report the incident to employee health.The procedure continued and was completed robotically.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the camera light guide for evaluation, and the failure analysis investigation has been completed.Failure analysis could not verify the customer reported complaint.Visual inspection displayed no physical damage.The camera light guide was unable to be tested for the heat complaint.No product issue was identified.The user manual cautions the user to turn off the illuminator before removing the light guide, and notes that it will take several minutes to cool off after use.It instructs to handle properly to avoid burns.

• Brand Name: NONE
• Common Device Name: CAMERA HEAD LIGHT GUIDE
• 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: 25409448
• Report Number: 2955842-2026-27549
• Device Sequence Number: 16034007
• Product Code: GCJ
• UDI-Device Identifier: 00886874115732
• UDI-Public: (01)00886874115732
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: 470042-03
• Device Catalogue Number: 470042
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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