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

Model Number 470184-12

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

The failure analysis evaluation and findings for the permanent cautery spatula have been reassessed.Failure analysis (fa) confirmed the customer reported issue as the permanent cautery spatula instrument was found to have thermal damage on the monopolar yaw pulley and distal clevis.Fa noted black char marks were present at the distal end and concluded any material missing from the damage of the yaw pulley was likely thermally inducted rather than mechanically induced.Fa removed one side of the distal clevis ear and the silicone potting did not appear compromised.The instrument conductor was not damaged around the weld location and passed an electrical continuity test.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A log review was performed for the permanent cautery spatula reported in this complaint (pn: (b)(4)) and the following was found: per logs, the instrument was last used on (b)(6) 2020 on system (sk2760) with 3 uses remaining.This complaint is being reported because there was evidence of thermal damage on the distal clevis and monopolar yaw pulley.Thermal damage on the distal clevis and monopolar yaw pulley 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.This report has been generated in response to fda inspectional observations dated 06-mar-2020.

Event Description

The permanent cautery spatula was identified in central processing to have a dark spot near the tip.The site noted that they could not clean the spot by washing.Intuitive surgical, inc.(isi) completed customer follow-up, but the customer could not provide any additional narrative regarding the complaint.Patient-related information was also requested, but was unavailable.

• 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: 10609839
• MDR Text Key: 209273734
• Report Number: 2955842-2020-11021
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112328
• UDI-Public: (01)00886874112328(10)N10180222
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470184-12
• Device Catalogue Number: 470184
• Device Lot Number: N10180222 0042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2018
• 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