MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SCHOELL; HANDHELD CAMERA LIGHT GUIDE

Model Number	470656-01
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that the after a da vinci-assisted cholecystectomy surgical procedure, the near infrared (nir) handheld camera light guide had a hole in the cable.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the initial reporter confirmed that the procedure was completed robotically with no injury or harm to the patient.The issue was noted after the procedure and did not affect the procedure.It was noted that the drape also had a hole.The issue did not cause any burns or harm to the patient or the staff.The handheld camera was not changed during the procedure.The nir handheld camera light guide will be returned for evaluation.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Failure analysis investigations replicated and confirmed the customer reported complaint.The camera cable was found to have a crack in the insulation.The damage was found near the middle of the cable.There were no wires exposed.The probable root cause of the damaged insulation is attributed to component susceptibility to damage through external collisions, during use, or during reprocessing.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SCHOELL
• Common Device Name: HANDHELD CAMERA 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: 24474407
• Report Number: 2955842-2026-06516
• Device Sequence Number: 13331588
• Product Code: NAY
• UDI-Device Identifier: 04250480109038
• UDI-Public: (01)04250480109038
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 04/09/2026

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: 470656-01
• Device Catalogue Number: 470656
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2025
• 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