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

Model Number	430151-02
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The sp fenestrated bipolar forceps was analyzed, and the findings did not replicate or confirm the customer reported event.The reported event with the instrument could not be replicated nor confirmed.Failure analysis could not verify the customer reported event.The instrument was placed and removed from the in-house system twice.In both attempts, the instrument jaws open and closed without a issues.The instrument jaws grasped an in-house sponge multiple times, and no issues were observed when releasing the sponge.The instrument was then installed on different arms, and no issues were observed with the instrument jaws opening and closing mechanism.The instrument moved intuitively with full range of motion in all directions.The instrument passed the recognition and engagement tests.The instrument passed energy delivery testing in various grip orientations.Visual inspection was performed and there were no external damage to the snake wrist, shaft, and housing.The instrument was fully functional.Based the investigation results, customer reported issues may be due to other factors unrelated to the product.Additional observation(s) not reported by site: the instrument was found to have residue.Visual inspection was preformed and white residue was observed on two of the clamping pulley located inside the backend of the instrument, the probable root cause of the customer-reported event could not be established as failure analysis did not replicate or confirm the issue.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sp fenestrated bipolar forceps instrument failed to release the tissue and the jaws had to be manually opened.The procedure was completed with no reported injury.

• 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: 25035834
• Report Number: 2955842-2026-23215
• Device Sequence Number: 10097472
• Product Code: NAY
• UDI-Device Identifier: 00886874123447
• UDI-Public: (01)00886874123447(10)K10260115
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: K10260115 0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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