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

Model Number	470655-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined.An intuitive surgical, inc.(isi) field service engineer (fse) site visit was performed, and a functional test performed of the nir handheld camera system and light source.No issues were found with operation of the devices.The fse verified that the light source can be turned on and off to standby mode.The fse verified that the handheld camera can change modes with the control buttons.The fse was unable to perform full system verification due to the system being in use.The fse provided technical documentation for use of light guide and reviewed the warnings/precautions for use with the robotics coordinator.The fse specifically reviewed section 3.1 page 16 of the schoelly light guide instructions for use (ifu).This section has precautions for light guide use regarding temperature after use.These precautions from the document will be printed and displayed in the operating room (or) for staff future use.After testing, these devices were deemed safe for use.A review of the site's system logs for the reported procedure date revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.
Event or Problem Description
It was reported that during a da vinci-assisted revision band to duodenal switch surgical procedure, the patient sustained a burn from the schoelly camera.The camera was turned off after use and left plugged in when stored in the sterile drape side pocket.The camera tip was still warm and the heat melted the sterile drape and left a burn on the patient the size of a quarter.Ointment was ordered for the burn.There was no additional tissue resection or further intervention required.There were no da vinci related complications or issues intraoperatively.The patient was reported to be doing well postoperatively.

• Brand Name: NONE
• Common Device Name: NIR HANDHELD CAMERA
• 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: 24407888
• Report Number: 2955842-2026-05304
• Device Sequence Number: 8223389
• Product Code: GCJ
• UDI-Device Identifier: 04250480109076
• UDI-Public: (01)04250480109076
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K221591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 470655-01
• Device Catalogue Number: 470655
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 02/20/2026
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female