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

Model Number	420183-16
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	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a permanent cautery hook instrument had corrosion.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The permanent cautery hook (pch) instrument was analyzed and found to have a broken distal clevis near the base of the clevis.There were no missing pieces observed.The instrument was also found to have a dislodged cable crimp at the distal end.Further evaluation found the pch instrument had a distal idler pulley broken.The broken portion of the idler pulley was not returned with the instrument.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) contacted the isi clinical sales executive and obtained the following information: the instrument was inspected prior to use, and no issues were noted with the functionality of the instrument during the surgical procedure.The instrument did not collide with any other instruments or other hard materials during the surgical procedure.There was no injury to the patient.The fragment(s) did not fall inside the patient.The instrument was removed during the procedure (prior to the breakage), and the wrist was straightened prior to removal.No additional surgical procedure was performed.Post-operative tests like an x-ray or ultrasound were not performed to check for remaining fragments.The patient did not return to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The fragment will not be returned to isi for evaluation.As per hospital protocol, patient information cannot be shared.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 18765074
• Report Number: 2955842-2024-11759
• Device Sequence Number: 14577677
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)K10221027
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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 351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/20/2024
• 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: 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 68 KG