MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; FENESTRATED BIPOLAR FORCEPS

Model Number	430151-02
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy procedure, tissue became entrapped in the jaws of a single port (sp) fenestrated bipolar forceps (fbf) instrument.While grasping tissue, the jaws failed to unclamp.Both the emergency stop (estop) button and the instrument release key (irk) were utilized; however, the jaws remained clamped on the tissue.To address the issue, an unspecified monopolar device was used to resect additional tissue, allowing for the removal of the sp fbf instrument.Additional information has been requested; however, no response has been received.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the single port (sp) fenestrated bipolar forceps (fbf) instrument for failure analysis evaluation.The sp fbf instrument was installed and tested on an in-house system and passed both recognition and engagement tests.It exhibited intuitive movement with full range of motion in all directions.The sp fbf instrument was retested and again, passed all in-house testing.The grips opened and closed properly during manual articulation and responded accurately to master tool manipulator (mtm) commands.No issues were observed with the operation of the jaws or grips.Inspection revealed no physical damage at the distal wrist.After removing the housing, no internal damage was identified.A log review indicated that an emergency power off was activated, but no instrument-related issues were found.The sp fbf instrument was fully functional, and no product issue was identified.
Additional Manufacturer Narrative
Additional information was received through follow-up.The surgical task being performed at the time of the event was instrument grasping.The uterine fibroid tissue resected with the monopolar curved scissors (mcs) instrument was planned for removal as part of the scheduled myomectomy procedure.No bleeding occurred as a result of the incident, and no blood transfusion was required.The procedure was completed robotically without further complication, and there are no concerns regarding long-term effects from this event.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• 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 ; 4085232100
• MDR Report Key: 24340965
• Report Number: 2955842-2026-04336
• Device Sequence Number: 20036396
• Product Code: NAY
• UDI-Device Identifier: 00886874123447
• UDI-Public: (01)00886874123447(11)251120(10)K10251120
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K241814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 430151-02
• Device Catalogue Number: 430151
• Device Lot Number: K10251120 0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/14/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female