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

Model Number	420172-18
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The maryland bipolar forceps instrument was analyzed.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument passed electrical continuity but energy delivery tests could not be completed in-house due to eft availability.The instrument moved intuitively with full range of motion in all directions.There were no issues with rotation during inspection.The instrument rotated without any problems.Additional observation related to customer reported complaint: the instrument was found to have severely bent grips, causing misalignment of the grips.There was a 0.0680¿ offset at the tips.The grips do not show cracking damage.This caused poor energy distribution as the jaws do not meet.The instrument passed electrical continuity but energy delivery tests could not be completed in-house due to eft availability.Components adjacent to this bent grip did show damage.The yaw has thermal damage.Additional findings not related to the customer reported complaint: the instrument was found to have charring and/or localized melting on the outer surface of one bipolar yaw pulley at the base of the grip.As a result of the damage, a section of the active electrode (grip) is exposed that would not normally be exposed.The instrument passed the electrical continuity test.The instrument was found to have a segment of the conductor wire dislodged and sticking out from the distal clevis.A loop of wire is sticking out such that the wire protrudes above the outer surface of the main tube.The wire insulation was not damaged, and the instrument passed an electrical continuity test.Components adjacent to the dislodged wire did show damage.The yaw pulley has thermal damage and the grips are bent severely.
Event or Problem Description
It was reported that during da vinci-assisted surgical procedure, the maryland bipolar forceps was found to have poor rotation and poor energy distribution.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: when appealing for instruments in the operating room, there was no feedback of wire damage, only the issue of energy distribution was reported, and the staff could not confirm whether the wire was damaged or not.Nurses and surgeons reported that no arc was seen during the operation.The hospital has reported that there have been no adverse events caused by the device.Attached are pictures of the equipment.The hospital is unable to provide patient 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: 20861642
• Report Number: 2955842-2024-22812
• Device Sequence Number: 8865278
• Product Code: NAY
• UDI-Device Identifier: 00886874111475
• UDI-Public: (01)00886874111475(11)230713(10)K10230713
• 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
• Report Date (Section B): 11/11/2024

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: K10230713 574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: Male