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

Model Number	420172-18
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the 8mm maryland bipolar forceps instrument involved with this complaint to perform failure analysis; however, the evaluation is not yet complete.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the insulation layer of the black guide wire at the head of the 8mm maryland bipolar forceps instrument was damaged.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the damage was first observed after the instrument was removed and did not cause any harm to the patient.
Additional Manufacturer Narrative
The instrument was analyzed and found to have damage of the conductor wire's insulation at the yaw pulley.There was no material missing and the conductor wires were exposed.The conductor wire insulation was damaged, the wire was damaged.The instrument passed an electrical continuity test.Components adjacent to the damaged wire insulation did not show damage.
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: 21340251
• Report Number: 2955842-2025-01325
• Device Sequence Number: 18250708
• Product Code: NAY
• UDI-Device Identifier: 00886874111475
• UDI-Public: (01)00886874111475(10)K10230427
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2025

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: K10230427 427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2025
• Supplement Date Received by Manufacturer: 02/08/2025
• Initial Report FDA Received Date: 02/08/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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