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

Model Number	420183-15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the 8mm permanent cautery hook instrument for failure analysis investigation.The instrument was analyzed and was found to have a broken distal pitch cable at the clevis hub.The broken cable segment that contains the crimp was still installed within the clevis.The cable was fully broken.There was no discoloration, corrosion, or contamination on the cable to suggest improper reprocessing as a contributing factor.Further inspection found no abnormally sharp or damaged components that could have contributed the cable breaking.Additional observation related to the customer reported complaint: the instrument was found to have a broken distal clevis at the ears of the clevis.The broken piece was not returned, measuring roughly 0.217 x 0.329¿ in size.Clevis does not show abrasions or scratches on the outer surface.Components adjacent to the broken clevis do not show damage.
Event or Problem Description
It was reported that the customer observed that the 8mm permanent cautery hook instrument was broken and the equipment was broken upon opening the package.There was no report of patient involvement.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PERMANENT CAUTERY HOOK
• 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: 20488918
• Report Number: 2955842-2024-20928
• Device Sequence Number: 3601079
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)K10230223
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/30/2024

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: 420183-15
• Device Catalogue Number: 420183
• Device Lot Number: K10230223 760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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