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

Model Number	420184-14
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive has received the part associated with this complaint and completed investigations.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of broken/loose cable to be related to the customer reported complaint.The instrument was found to have a frayed pitch cable at the distal end.Additional observation(s) not reported by site: the instrument was found to have the plastic proximal clevis broken.The broken piece is missing as a result of breakage.The size of missing piece is approximately 0.023¿ x 0.053¿.This failure is most commonly caused by mishandling/misuse, such as excess force applied to the distal end of the instrument.Blank mdr fields: follow-up was attempted, but the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the cable was damaged.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: 17015541
• Report Number: 2955842-2023-14679
• Device Sequence Number: 7538668
• Product Code: NAY
• UDI-Device Identifier: 00886874111543
• UDI-Public: (01)00886874111543(10)N10190715
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 01/27/2021

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: 420184-14
• Device Catalogue Number: 420184
• Device Lot Number: N10190715 876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2019
• 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: Unknown