MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CURVED BIPOLAR DISSECTOR

Model Number	470344-14
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting a recognition issue, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm the customer reported complaint.The instrument was placed and driven on an in-house system after getting the grip tips unstuck.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.A review of the log shows no errors.Further investigation found that the instrument grip tips were stuck and unable to manually articulate the grip tips.The instrument was also found to have a segment of the conductor wire sticking out from the yaw pulley.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.The root cause of this failure is attributed to a component failure.
Event or Problem Description
It was reported that during a da vinci-assisted procedure, the surgeon was unable to gain control of the curved bipolar dissector.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Common Device Name: CURVED BIPOLAR DISSECTOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 17015909
• Report Number: 2955842-2023-15028
• Device Sequence Number: 20565054
• Product Code: NAY
• UDI-Device Identifier: 00886874112489
• UDI-Public: (01)00886874112489(10)S10161223
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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: 470344-14
• Device Catalogue Number: 470344
• Device Lot Number: S10161223 0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 05/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2016
• 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