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

Model Number	420172-18
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The instrument was installed on an in-house system and passed the recognition test.A review of the logs found 1 - 31009 error relating to recognition failure.Visual inspection found no damage to the dallas chip.Additionally, the instrument was found to have thermal damage to 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.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the maryland bipolar forceps instrument had a recognition issue.The procedure was continued as planned with no reported injury.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: there was no thermal damage and arcing observed.There was no adverse event reported.

• 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: 21352434
• Report Number: 2955842-2025-01432
• Device Sequence Number: 9079141
• Product Code: NAY
• UDI-Device Identifier: 00886874111475
• UDI-Public: (01)00886874111475(10)K10240125
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/22/2025

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: K10240125 189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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: Prefer Not To Disclose