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

Model Number 420183-12

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2019

Event Type  malfunction  

Manufacturer Narrative

The failure analysis evaluation and findings have been reassessed.Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) confirmed the customer reported issue that ¿a patch of the black ceramic sleeve at the distal end of the instrument was missing¿ from the permanent cautery hook instrument.The permanent cautery hook instrument was found to have a broken ceramic sleeve and the broken piece was not returned.The size of missing piece was approximately.113" x.133".This failure is most commonly caused by mishandling/misuse, such as excess force applied to the distal end of the instrument or accidental collisions.Additional information not reported by site: the permanent cautery hook instrument was found to have thermal damage on the monopolar yaw pulley at the ceramic sleeve location with no evidence or claim of user mishandling or misuse.This is a reportable event due to the following conclusion: thermal damage on the monopolar yaw pulley at the ceramic sleeve location is evidence of electrical discharge at a location other than intended.While there was no harm or injury to patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Image/video review: no investigation required as no image or video clip for the reported event was submitted for review.Blank mdr fields: follow-up was attempted, but the patient information was either unknown or unavailable.Device expiration date was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.Per log review, the permanent cautery hook instrument had 4 lives remaining when it was returned to isi and, therefore, had not expired.Implant date is blank because the product is not implantable.This report has been generated in response to fda inspectional observations dated march 6, 2020.

Event Description

During a da vinci-assisted surgical procedure, it was reported that a patch of the black ceramic sleeve at the distal end of a permanent cautery hook instrument was missing.The surgeon found the lost patch during the surgery, and took it out intact.The procedure was completed utilizing the same permanent cautery hook instrument with no reported patient harm or injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: the surgeon assistant found the broken fragment under the endoscope.All broken fragments were retrieved and no additional surgical procedure was required.No post-operative tests were performed to check for remaining fragments.The customer suspected the reported instrument had a quality issue.The instrument was used almost until the end of the case.The instrument was inspected prior to use and there was no damage noted.The surgeon was dissecting and separating tissue prior to the breakage.There was no report of instrument collision.The instrument was not removed during the procedure.The customer had no issues upon final removal of the instrument.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.Isi completed further follow-up and the site could not provide any additional narrative to the complaint and patient demographic information was unavailable.

• Brand Name: ENDOWRIST
• Type of Device: 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: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10008012
• MDR Text Key: 189294045
• Report Number: 2955842-2020-10365
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)N10180529
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420183-12
• Device Catalogue Number: 420183
• Device Lot Number: N10180529 700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1