MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PERMANENT CAUTERY SPATULA

Model Number	420184-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The pcs instrument was analyzed and found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in the clevis.Common causes of this failure mode are attributed to a component failure.When pitch cable breakage occurs, the instrument is immediately inoperable due to loss of functionality.The instrument has tungsten drive cables to transmit motion from the input discs in the housing, through the main shaft, and to the distal instrument tip.These cables are exposed at the instrument tip and control movements at the wrist.
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, there was a stopping point when the angle of the permanent cautery spatula instrument changes from 60 degrees on the left to 60 degrees on the right.The instrument was also identified with a broken cable.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PERMANENT CAUTERY SPATULA
• 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: 17102494
• Report Number: 2955842-2023-16216
• Device Sequence Number: 7377268
• Product Code: NAY
• UDI-Device Identifier: 00886874111543
• UDI-Public: (01)00886874111543(10)N10210913
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2023

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: 420184-14
• Device Catalogue Number: 420184
• Device Lot Number: N10210913 581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 06/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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: Female