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	08/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi), has not received the da vinci product with an alleged issue to perform failure analysis.A review of the provided image was performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The following additional information was provided: the images show a long bipolar grasper with thermal damage between the grips.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the long bipolar grasper instrument stopped coagulating and started to smell burnt.The ceramic component at the tip of the instrument appears to have overheated.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: no arcing was observed.The non-energy instrument did not come into contact with or collide with another activated energy instrument during the procedure.

• 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: 50618888
• Report Number: 2955842-2026-37899
• Device Sequence Number: 10500049
• Product Code: NAY
• UDI-Device Identifier: 00886874121528
• UDI-Public: (01)00886874121528(11)260122(10)K12260122
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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: K12260122 0034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2026
• 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