MAUDE Adverse Event Report: SCHOELLY FIBEROPTIC GMBH DA VINCI; NIR HANDHELD CAMERA

Model Number	470655-01
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified da vinci-assisted surgical procedure, the schoelly handheld camera was not connecting, and color bars were displayed on the monitor of the vision side cart (vsc).The customer stated they have had multiple connection issues with the schoelly handheld camera associated with this event.It was stated they would clean the camera connector with an alcohol wipe and "sometimes that would fix the connection issue." however, once sent through the sterilization process it would no longer connect.A backup schoelly handheld camera was requested and installed which caused a 5-minute surgical delay.The procedure was completed robotically with no reported patient injury, and the patient was discharged home the same day.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the schoelly handheld camera to perform failure analysis.However, as of the date of this report, the evaluation of the schoelly handheld camera has not been completed.

• Brand Name: DA VINCI
• Common Device Name: NIR HANDHELD CAMERA
• Manufacturer (Section D): SCHOELLY FIBEROPTIC GMBH; robert-bosch-strasse 1-3; denzlingen 79211 ; GM 79211
• 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: 24629829
• Report Number: 2955842-2026-16616
• Device Sequence Number: 9015311
• Product Code: GCJ
• UDI-Device Identifier: 04250480109076
• UDI-Public: (01)04250480109076
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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: 470655-01
• Device Catalogue Number: 470655
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/18/2026
• 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