MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CAMERA, 0°

Model Number	430077-05
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope instrument has been received for failure analysis evaluation.The endoscope was found to have failed self-test.The endoscope was placed on an in-house sp system to test the qap (quality assurance procedures) and failed.Upon inserting the endoscope into the system, an error stating "endoscope self-test failed.Clean connector or replace endoscope" appears, indicating a self-test failure.A review of field log found error code that was pointing to camera and communication issue and illuminator time out.The customer reported complaint was replicated and confirmed.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a camera self-test failed, and it could not be resolved by reconnecting the connector or performing a power cycle on the system.The technical service engineer (tse) confirmed error 48221 and advised the customer to clean the connector and reconnect it again, but the issue persisted.The tse advised the customer to change to another camera; however, he did not have a backup camera, so he decided to convert the surgery to laparoscopic.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use and no damage or abnormalities were found.During the procedure, a camera malfunction occurred before the timeout, and since there was no sterile spare camera available, it was necessary to convert to a traditional laparoscopic approach.The patient tolerated the change well, and there was no injury or health damage reported as a result of the conversion.

• Brand Name: ENDOWRIST SP
• Common Device Name: CAMERA, 0°
• 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: 24465247
• Report Number: 2955842-2026-14438
• Device Sequence Number: 10262083
• Product Code: IZI
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: 430077-05
• Device Catalogue Number: 430077
• Device Lot Number: N/A
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown