MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; BIPOLAR GRASPER, LONG

Model Number	470400-09
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The long bipolar grasper instrument was analyzed and found to have a broken conductor wire within the bipolar yaw pulley, between the wire crimp on the grip and the silicone potting sealing the wire entrance to the yaw pulley.The instrument failed the electrical continuity test.The wire was fully broken, and the conductor wires were exposed.No signs of thermal damage were observed.Components adjacent to the broken wire did not show damage.Additional observation found unrelated to the reported complaint states that the instrument had a broken bipolar yaw pulley at the grip hub.Broken pieces were missing as a result of the breakage.The size of the missing piece was approximately 0.1315¿ x 0.0076¿.The electrode was also exposed.The components surrounding the break did not exhibit damage that would have contributed to the broken yaw pulley.The complaint was confirmed by failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the long bipolar grasper instrument had a broken conductor wire.The instrument was removed and replaced with a backup.Following this, the user continued with the procedure without further issues.No fragment fell inside the patient.No known impact or patient consequence was reported.

• Brand Name: ENDOWRIST
• Common Device Name: BIPOLAR GRASPER, LONG
• 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: 19766668
• Report Number: 2955842-2024-16975
• Device Sequence Number: 8514284
• Product Code: NAY
• UDI-Device Identifier: 00886874113530
• UDI-Public: (01)00886874113530(10)N10190302
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150837
• 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
• Report Date (Section B): 06/19/2024

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: 470400-09
• Device Catalogue Number: 470400
• Device Lot Number: N10190302 0124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2019
• 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