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

Model Number	420183-16
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in central processing, while cleaning the instrument, the "small gray plastic bolt" was observed to be missing from the permanent cautery hook (pch) instrument.It is unknown when the fragment broke, if a patient was involved or what caused the breakage to occur.Intuitive surgical, inc.(isi) contacted the site for additional information; however, at the time of this report, no further details have been provided.
Additional Manufacturer Narrative
Based on the information provided, the cause of the customer reported failure mode cannot be determined.Intuitive surgical, inc (isi) has not received the permanent cautery hook instrument that was used during this reported event; therefore, failure analysis investigations (fa) cannot be performed.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive permanent cautery hook (pch) instrument to perform failure analysis (fa).Fa did confirm the customer reported complaint and found the primary finding of broken yaw pulley at the posts.The broken piece is approximately 0.059¿ x 0.044¿ and is missing as a result of the breakage.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PERMANENT CAUTERY HOOK
• 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: 18809494
• Report Number: 2955842-2024-11824
• Device Sequence Number: 7310874
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)K10221027
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup
• Report Date (Section B): 02/02/2024

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: 420183-16
• Device Catalogue Number: 420183
• Device Lot Number: K10221027 369
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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: Unknown
• 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