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

Model Number	420184-14
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The permanent cautery spatula 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.The instrument was also found to have a derailed grip cable at the distal idler pulley.The yaw motion may be non-intuitive as a result.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.The complaint was confirmed by failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the permanent cautery spatula had a broken wire.The user completed the procedure with no further issue reported.No fragment fell inside the patient's anatomy.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use and found to be broken.The instrument was not used on the patient.

• 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: 18433188
• Report Number: 2955842-2024-10005
• Device Sequence Number: 17900788
• Product Code: NAY
• UDI-Device Identifier: 00886874111543
• UDI-Public: (01)00886874111543(10)N12210308
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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: N12210308 259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2021
• 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: Initial
• 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