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

Model Number	431150-02
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The force bipolar instrument used during this event was not received for failure analysis investigations.
Event or Problem Description
It was reported that during a da vinci-assisted bilateral inguinal lymphadenectomy single port surgical procedure, the force bipolar instrument entrapped lymph node fatty tissue.This event occurred when the tissue was grasped, but the force bipolar instrument would not open.The instrument release kit (irk) failed to successfully open the jaws of the instrument.This was a lymph node dissection procedure, and the monopolar curved scissors instrument was then used to cut the fatty lymph node tissue around the jaws of the instrument in order to remove the instrument.The surgeon confirmed there was no significant bleeding, however, it is unknown if cautery was used.In addition, the surgeon reported there was no injury to the patient.The surgery was completed with no other complications.On 18-mar-2026, intuitive surgical, inc.(isi) received user facility report 4900320000-2026-8003 stating: "during the procedure, the instrument was grasping tissue and would not ungroup.Troubleshooting was preformed but the surgeon had to cut the tissue that the instrument was grasping in order to remove the instrument from the robot.".

• 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: 24884315
• Report Number: 2955842-2026-21237
• Device Sequence Number: 10564740
• Product Code: NAY
• UDI-Device Identifier: 00886874124055
• UDI-Public: (01)00886874124055(10)K10260115
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

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: 431150-02
• Device Catalogue Number: 431150
• Device Lot Number: K10260115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2026
• 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
• Patient Sex: Unknown