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

Model Number	430151-02
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the instrument; however, intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the reported failure mode has not yet been determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.
Event or Problem Description
It was reported that during da vinci-assisted benign hysterectomy surgical procedure, the jaws of single port fenestrated bipolar forceps instrument were not moving correctly.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue occurred while the surgeon was using the surgeon console's high resolution stereo viewer and attempting to manipulate instruments, with the instrument not moving as desired and the coagulation function was not working.The instrument did not exhibit shakiness or friction, and there was no interference or collision with other instruments or system arms.The problem was resolved by replacing the instrument, which then functioned correctly, indicating the issue was likely with the instrument itself rather than the drape or other system components.No patient injury occurred, and the instrument was inspected prior to use with no visible damage.The instrument is available for return for evaluation, but no photographic or video evidence is available.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The single port fenestrated bipolar forceps instrument was analyzed, and the complaint was not confirmed by failure analysis.The instrument was placed and driven on an in-house system, and it passed the recognition and engagement tests.The single port fenestrated bipolar forceps instrument passed energy delivery and moved intuitively with full range of motion in all directions and the grips opened and closed properly.The instrument was retested and passed all in-house testing on both attempts.The instrument was fully functional.There was no physical damage at the distal wrist.The housing was removed for inspection and found no damage.No product issue was identified.

• 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: 24490303
• Report Number: 2955842-2026-14705
• Device Sequence Number: 5105142
• Product Code: NAY
• UDI-Device Identifier: 00886874123447
• UDI-Public: (01)00886874123447(11)250515(10)K10250515
• 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): 03/30/2026

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: 430151-02
• Device Catalogue Number: 430151
• Device Lot Number: K10250515 0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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: Female