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

Model Number 470184-13

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

The permanent cautery spatula (pcs) instrument has been returned and evaluated by the failure analysis team.Failure analysis investigations replicated/confirmed the customer reported complaint "yellow plastic on distal end melted during cauterizing." failure analysis found the primary failure of thermal damage yaw pulley thermal damage at the sleeve to be related to the customer reported complaint.The instrument was found to have thermal damage at the sleeve on the monopolar yaw pulley and subsequent thermal damage to distal clevis and conductor wire cap.No insulation damage on the conductor wire was observed.Electrical continuity was performed and passed.The root cause of this failure is attributed to device design.Additional observations not reported by site that are related to the customer reported complaint were that the instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.068¿ - 0.188" in length and were not aligned with the tube axis.The root cause of scratch marks /abrasions instrument main tube is typically attributed to mishandling/misuse.A review of the site's complaint history does not show any additional complaints related to this product or this event.No image or procedure video was provided for review.A review of the instrument log for the permanent cautery spatula instrument (470184-13/n10201012 0024) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2021.The procedure was a tongue base resection malignant on system rsk8030.This complaint is being reported based on the following conclusion: there was evidence of thermal damage to the ceramic sleeve with no indication or claim of user mishandling or misuse.Thermal damage proximal to the ceramic sleeve is evidence of electrical discharge at a location other than intended.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Initial reporter also sent report to fda?: is blank because it is unknown if the initial reporter submitted a report to the fda.Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the yellow plastic on distal end of the permanent cautery spatula instrument melted during cauterizing.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY SPATULA
• 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: 12929965
• MDR Text Key: 281729019
• Report Number: 2955842-2021-11661
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112328
• UDI-Public: (01)00886874112328(10)N10201012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470184-13
• Device Catalogue Number: 470184
• Device Lot Number: N10201012 0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.