MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; VISION SYSTEM CART

Model Number	380941-51
Medical Device Problem Code	Grounding Malfunction (1271)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to a single port (sp) da vinci-assisted simple extraperitoneal prostatectomy procedure, the grey neutral wire where it connects to the single port (sp) energy shield monitor (esm) was stripped and had been pulled out.The issue was identified after anesthesia induction but prior to port placement.An intuitive surgical, inc.(isi) technical support engineer (tse) advised the customer that no monopolar energy would be available without that connection and the system could not be used with a third party generator.The caller indicated that the customer was planning on getting an esm from another system that was not in use at another site.However, the tse advised the caller using a different esm was not recommended and should not be performed.The tse informed the caller that an fse would be required to replace the esm.Due to the issue, the customer elected to convert the case to a da vinci multi-port system which required more incisions that originally planned.It was reported the patient tolerated the conversion with no post-operative complications reported.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Based on the field evaluation, this reported event was confirmed.The fse replaced the energy shield monitor (esm) to resolve the issue.The system was tested and verified as ready for use.The energy shield monitor (esm) was returned for failure analysis.The customer's reported complaint was confirmed and replicated.Upon visual inspection, the grey neutral cable was found damaged.

• Brand Name: DA VINCI SP
• Common Device Name: VISION SYSTEM CART
• 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: 24899420
• Report Number: 2955842-2026-21045
• Device Sequence Number: 21047582
• Product Code: NAY
• UDI-Device Identifier: 00886874114742
• UDI-Public: (01)00886874114742
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 380941-51
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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: 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