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

Model Number	470344-14
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the curved bipolar dissector had misaligned tips.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The curved bipolar dissector instrument was analyzed and found to have a bent grip, causing side-to-side misalignment of the grips.There was a 00475¿ offset at the tips.Additionally, the instrument was found to have damaged conductor wire insulation with exposed wire at the distal end.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests and moved intuitively with full range of motion in all directions the instrument passed electrical continuity and energy delivery tests.There was no thermal damage and no missing material.The instrument was also found to have a dislodged conductor wire at the distal end.The instrument was found to have a segment of the conductor wire sticking out.A loop of wire is sticking out such that the wire protrudes above the outer surface of the main tube.The complaint was confirmed by failure analysis.

• 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: 18034447
• Report Number: 2955842-2023-19736
• Device Sequence Number: 8277650
• Product Code: NAY
• UDI-Device Identifier: 00886874112489
• UDI-Public: (01)00886874112489(10)N10161124
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2023

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: N10161124 0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2016
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White