MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist;daVinci Si; FENESTRATED BIPOLAR FORCEPS

Model Number	420205-17
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2026
Type of Reportable Event	Other
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the lead surgeon noticed sparks coming from the tip of the fenestrated bipolar forceps instrument while performing uterine coagulation.The arcing appeared to originate from equipment, wrists, insulating materials and places.The arc grounded on patient anatomy when the bipolar energy was activated.Burnt insulation was noticed.The instrument tips did not collide with any other instrument or tool during procedure.It was reported that there was no patient injury.The procedure was completed as planned.
Additional Manufacturer Narrative
The fenestrated bipolar forceps instrument has not been received for investigation.

• Brand Name: EndoWrist;daVinci Si
• Common Device Name: FENESTRATED BIPOLAR FORCEPS
• 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 ; +1(408)523-2100
• MDR Report Key: 50933194
• Report Number: 2955842-2026-40267
• Device Sequence Number: 16142222
• Product Code: NAY
• UDI-Device Identifier: 00886874111642
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 420205-17
• Device Catalogue Number: 420205
• Device Lot Number: K10260305 584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2026
• 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: Other
• Patient Sex: Unknown