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

Model Number	420205-16
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the fenestrated bipolar forceps instrument associated with this complaint and completed investigations.The instrument was found to have damage of the conductor wire insulation at the yaw pulley.There was no material missing, and the conductor wires were exposed.The conductor wire was not frayed or broken.The instrument passed an electrical continuity test.Components adjacent to the damaged wire insulation did not show damage.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 8mm fenestrated bipolar forceps instrument could not be use.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: instrument remained static.No physical damage was noted nor issues related to cautery.There was no missing nor detached material from the portion that enters the patient's body.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The probable root cause of the damaged insulation on the instrument¿s conductor wire-bipolar is attributed to mechanical impact, such as accidental drops, inadvertent collisions with other instruments, or contact with hard surfaces during handling or use.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: FENESTRATED 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: 22855269
• Report Number: 2955842-2025-34931
• Device Sequence Number: 12867150
• Product Code: NAY
• UDI-Device Identifier: 00886874111642
• UDI-Public: (01)00886874111642(10)K10240523
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• 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,Followup
• Report Date (Section B): 08/14/2025

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: 420205-16
• Device Catalogue Number: 420205
• Device Lot Number: K10240523 759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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