MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; FORCE BIPOLAR ER

Model Number	431150-01
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the force bipolar instrument would engage in a different direction than the surgeon was trying.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force bipolar extended range instrument was analyzed, and the complaint was not confirmed by failure analysis.The instrument was placed and driven on an in-house system and moved intuitively with full range of motion in all directions and passed intuitive motion with no issues observed.The instrument passed the recognition and engagement tests.The grips opened and closed properly.The instrument passed energy delivery testing in various grip orientations.The instrument also passed the electrical continuity test.The instrument was retested and passed all in-house testing on three attempts.The instrument was fully functional.There was no physical damage.The housing was removed for inspection and found no damage.No product issue was identified.

• Brand Name: ENDOWRIST SP
• Common Device Name: FORCE BIPOLAR ER
• 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: 24503552
• Report Number: 2955842-2026-14688
• Device Sequence Number: 15958884
• Product Code: NAY
• UDI-Device Identifier: 00886874124055
• UDI-Public: (01)00886874124055(10)H10250725
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K241814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: 431150-01
• Device Catalogue Number: 431150
• Device Lot Number: H10250725 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• 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: 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