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

Model Number	420183-15
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the permanent cautery hook tip was broken.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer reported that unfortunately they did not have further info for this event and that all that they were aware of was that the issue was noted prior to procedure during the case cart check.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The permanent cautery hook was analyzed and found to have an ear of the distal clevis broken off.The broken piece was not returned, measuring roughly 0.303¿ x 0.217¿ in size.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.

• Brand Name: ENDOWRIST
• 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: 18433175
• Report Number: 2955842-2023-21884
• Device Sequence Number: 15227001
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)M10100224
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care 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: 420183-15
• Device Catalogue Number: 420183
• Device Lot Number: M10100224 128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• 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: 10/16/2023
• 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: Unknown