MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CURVED BIPOLAR DISSECTOR

Model Number	470344-16
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the intuitive device returned.However, isi has not received the curved bipolar dissector instrument involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted pancreatectomy - distal surgical procedure, there was arcing.The surgeon used a third-party generator (integrated electrosurgical unit (iesu) or erbe vio3) with their pedal and with our bipolar cable.At the surgery using the cut bipolar with the third party, it caused arcing between the jaws of the curved bipolar dissector instrument.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: no damage to the instrument was noted after the arcing event.The instrument was inspected prior to use with no damage observed.A pin gage was used to inspect the cannula.The bipolar was connected with the bipolar cord to an external erbe vio 3 generator.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The curved bipolar dissector instrument was analyzed, and the complaint was not confirmed by failure analysis.The instrument was visually inspected internally and externally with no issues identified.The instrument passed the grip test.The instrument was tested on an in-house system and passed the recognition and engagement tests.The grip tips opened and closed properly.The instrument passed energy delivery testing in various grip orientations.The instrument also passed the electrical continuity test.The instrument was fully functional.No product issue was found.The instrument was found to have charring and localized melting at the yaw pulley.No conductor wire damage was observed.The probable root cause of thermal damage is attributed to carbonized tissue on the grips of this bipolar instrument creating a conductive path during use.

• Brand Name: ENDOWRIST
• Common Device Name: CURVED BIPOLAR DISSECTOR
• 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: 21768298
• Report Number: 2955842-2025-13311
• Device Sequence Number: 8676065
• Product Code: NAY
• UDI-Device Identifier: 00886874112489
• UDI-Public: (01)00886874112489(10)N10190103
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: 470344-16
• Device Catalogue Number: 470344
• Device Lot Number: N10190103 0098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2019
• 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: Reuse
• 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