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

Model Number 470184-11

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585)

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

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery spatula instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) confirmed the reported complaint "wrist isolation was no function and charring." the instrument was found to have thermal damage on the monopolar yaw pulley with no conductor wire damage found.Fa noted that the instrument passed the electrical continuity test.Additionally, the instrument was found to have thermal damage on the distal clevis and conductor wire cap.Fa noted that the conductor wire cap was lost while the instrument was in house.The instrument was further analyzed by an isi failure analysis engineer (fae).An isi fae noted that the thermal damage observed on the distal clevis seemed to originate at the base of the ceramic sleeve.Fae indicated that thermal damage may have occurred during air-firing (i.E.Energizing the cautery instrument without the tip in contact with tissue), which can cause conductive fluids or tissue around the base of the ceramic sleeve to carry stray energy via capacitive coupling.This complaint is a reportable event due to the following conclusion: thermal damage at the instrument yaw pulley, distal clevis and distal cap 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 log review was performed for the permanent cautery hook reported in this complaint (pn: 420184-11/n10160808 0025) and the following was found: per logs, the instrument was last used on 03/04/2019 on system (sk0715) with 7 uses remaining.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Image review: images were provided by site that showed charring at the wrist of the instrument.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.This reported issue occurred on the instrument's third usage and, therefore, the instrument 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 06-mar-2020.

Event Description

It was reported that during a da vinci-assisted tongue base resection surgical procedure, there was no wrist isolation function and charring/smoking was observed on a permanent cautery spatula instrument.The customer stopped using the permanent cautery spatula instrument and replaced it with a back-up permanent cautery spatula instrument.There was no report of fragment(s) falling inside the patient.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer was using an erbe vio dv generator with the monopolar electrosurgical unit (esu) settings set to swift coagulation (power setting 2) and autocut (power setting 3).The permanent cautery spatula instrument and cannula were inspected for damage prior to use with nothing unusual observed.The reported issue occurred approximately 30 minutes into the procedure.The customer did not see any sparks or any indication of arcing.The customer did see smoke from the instrument tip's side while activating coagulation energy.The permanent cautery spatula instrument was removed a couple of times to clean up the tip side (charring), but the customer did not notice the issue at the time.The permanent cautery spatula instrument's wrist was straightened upon removal.Reported instrument did collide, but it was minor and "not serious".Surgeon believed the instrument¿s wrist was too close the tissue to cause the isolation lost function.The isolation defect to make instrument¿s wrist charring.Procedure was tors.Removed right side tongue base.Intuitive surgical, inc.(isi) completed additional follow up and confirmed there was no patient injury.The available patient demographic information has been documented in the patient information.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY SPATULA
• 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: 10008001
• MDR Text Key: 189295625
• Report Number: 2955842-2020-10359
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112328
• UDI-Public: (01)00886874112328(10)S10160808
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K131861
• 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: 05/02/2019

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: 470184-11
• Device Catalogue Number: 470184
• Device Lot Number: S10160808 0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Date Manufacturer Received: 05/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2016
• 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
• Patient Age: 65 YR