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

Model Number	471400-12
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.The long bipolar grasper instrument was placed and driven on an in-house system.The long bipolar grasper instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The long bipolar grasper grip tips opened and closed properly.The long bipolar grasper passed the grip test.The long bipolar grasper instrument passed energy delivery testing in various grip orientations.The long bipolar grasper instrument also passed the electrical continuity test.The long bipolar grasper was fully functional.No product issue was found.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 8mm long bipolar grasper instrument had intra-abdominal sparks had occurred.The procedure was completed with no reported injury.

• 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 ; 4085232100
• MDR Report Key: 25672865
• Report Number: 2955842-2026-30505
• Device Sequence Number: 10452402
• Product Code: NAY
• UDI-Device Identifier: 00886874121528
• UDI-Public: (01)00886874121528(11)250918(10)K10250918
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: K10250918 0435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• 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