MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MARYLAND BIPOLAR FORCEPS

Model Number	420172-18
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, no notification was made during the surgery, a cut cord was found.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
An investigation is in progress to determine the cause an rma was issued to evaluate the intuitive surgical, inc.(isi) device.Of this reported event.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The maryland bipolar forceps was analyzed and found that failure analysis investigations replicated/confirmed the customer reported complaint."no notification was made during the surgery, and a cut cord was found.The instrument had 7 remaining uses.Failure analysis found the primary failure of broken conductor wire to be related to the customer reported complaint.The instrument was found to have a broken conductor wire within the bipolar yaw pulley, between the wire crimp on the grip and the silicone potting sealing the wire entrance to the yaw pulley.The instrument failed the electrical continuity test.The wire was fully broken, and the conductor wires we exposed.No signs of thermal damage were observed.Components adjacent to the broken wire do not show damage.Common causes of broken instrument conductor wire - bipolar are attributed to when the instrument is moved by the surgeon in a grasp/pull/pitch motion, its grip can become dislocated/dislodged and may pull the conductors wire out of the routing groove.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause is attributed to component failure.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MARYLAND 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: 22198460
• Report Number: 2955842-2025-25329
• Device Sequence Number: 9739817
• Product Code: NAY
• UDI-Device Identifier: 00886874111475
• UDI-Public: (01)00886874111475(10)K10240404
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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: 420172-18
• Device Catalogue Number: 420172
• Device Lot Number: K10240404 0629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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