MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist; BIPOLAR GRASPER, LONG

Model Number	471400-12
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy without lymphadenectomy surgical procedure, the surgeon lost complete vision on the console while the prograsp forceps was grasping tissue.A system restart was done, but the system could not complete its self-checks since two instruments, a prograsp forceps instrument and a long bipolar grasper instrument, were grasping tissue.The system was put into an emergency state, and the instruments had to manually be opened with the emergency tool kit.The tissue was removed and the instruments were removed.The system was resumed for use, and the self-check was completed.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the distributor clinical sales representative (csr) and obtained the following additional information: the customer confirmed the long bipolar grasper was the other instrument involved and reported that both instruments were on tissue and had to be manually opened and removed using the instrument release kit (irk).Once the jaws were successfully opened, an assistant used a laparoscopic grasper to detach and remove the tissue caught between the jaws of the robotic instruments.The tissue was not removed from the patient, only from the instrument jaws, and did not require repair.The instruments were then removed and the system was restored.There was no patient or tissue injury, no unexpected tissue removal, and no bleeding or blood loss beyond the anticipated amount as a result of the unclamping issue.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.

• Brand Name: EndoWrist
• Common Device Name: BIPOLAR GRASPER, LONG
• 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: 50948888
• Report Number: 2955842-2026-40291
• Device Sequence Number: 10348770
• Product Code: NAY
• UDI-Device Identifier: 00886874121528
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 471400-12
• Device Catalogue Number: 471400
• Device Lot Number: K11251014 0213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• 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