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	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The long bipolar grasper instrument was analyzed and found to have damaged conductor wire insulation at the yaw pulley.The yaw pulley was found to have charring and localized melting of both bipolar yaw pulleys, in the space between the grips.The instrument passed the electrical continuity test.The complaint regarding melted at the distal end where the wires are manipulator was confirmed by failure analysis.The probable root cause of thermal damage on the bipolar yaw pulley can be attributed to insulation degradation and carbonized tissue creating a conductive path.
Event or Problem Description
It was reported that during central processing, the distal tip of a long bipolar grasper instrument appeared melted/burnt in area of manipulator wires.There was no report of patient involvement or patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: it was unknown if arcing was observed.There was no injury to the patient.

• 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: 25662478
• Report Number: 2955842-2026-30478
• Device Sequence Number: 16047169
• Product Code: NAY
• UDI-Device Identifier: 00886874121528
• UDI-Public: (01)00886874121528(11)250821(10)K10250821(91)0005
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: 471400-12
• Device Catalogue Number: 471400
• Device Lot Number: K10250821 0140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2026
• 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: 08/21/2025
• 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 Age: 37 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White