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

Model Number	420183-06
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive an instrument on which to perform failure analysis investigations.Although the complaint was not confirmed by failure analysis since the product was not returned, the information gathered indicates that the device may have contributed to the customer reported issue.A review of the provided image was performed by an isi failure analysis engineer.The following additional information was provided: the ceramic sleeve was broken, and the hook assembly had separated from the instrument.
Event or Problem Description
It was reported that during a da vinci-assisted isolated nissen fundoplication surgical procedure, the permanent cautery hook instrument broke and fragments fell inside the patient.The clinical territory associate (cta) stated all fragments have been removed from the patient.The customer replaced the instrument with a backup and completed the procedure.Intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: the hook had come loose, an image of the damage was provided for review.A return of the instrument was made by the pharmacy but the reporter did not have the information.The hook was retrieved with a celio clip.The issue occurred during dissection.The instrument was in use for approximately 45 mins prior to the incident.According to the reporter, it was a very old instrument that had multiple sterilization cycles.The surgeon noticed that the instrument did not coagulate well.The instrument did not collide with any other instruments or other hard material during the surgical procedure.The instrument was not removed before it ruptured.During final removal of the instrument, the wrist was straightened the surgical staff did not feel any resistance when removing the instrument through the cannula.The hook was retrieved, there were no other fragments.Further surgery was not required to remove the fragments (i.E.Laparoscopy or open procedure).A post-operative test (x-ray) was performed to check for remaining fragments.The patient had not returned to the hospital because of post-operative complications related to foreign body retention.

• 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: 18979047
• Report Number: 2955842-2024-12498
• Device Sequence Number: 15110603
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)M10130104
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420183-06
• Device Catalogue Number: 420183
• Device Lot Number: M10130104 158
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2013
• 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