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

Model Number 420184-11

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 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

On 6/14/2020, intuitive surgical, inc.(isi) completed its evaluation of the permanent cautery spatula instrument.Failure analysis (fa) confirmed the customer reported issue as the instrument was found to have thermal damage on the distal clevis.Fa removed the clevis ear and no conductor wire insulation damage or broken conductor wire was observed at the weld.The instrument passed the electrical continuity test and was found to have 2 lives remaining based on the logs.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 sh2073, with 2 uses remaining.The permanent cautery spatula instrument allegedly ¿short circuited¿ (i.E.Potentially arced) with no evidence or claim of user mishandling or misuse.This complaint is being reported because there was evidence of thermal damage on the distal clevis.Thermal damage on the distal clevis 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

It was reported that during a da vinci-assisted wedge resection procedure, performed on (b)(6) 2018, there was a "short circuit" with the permanent cautery spatula (pcs) instrument.The surgical staff completed the procedure and there was no reported patient injury.Intuitive surgical, inc.(isi) completed customer follow-up and obtained the following information: the customer is unable to provide any additional narrative regarding the event.The customer indicated that the surgical staff routinely checks instruments prior to insertion and checks cannulas with the gage pins.Additional patient-related information was also requested, but was unavailable.

• Brand Name: ENDOWRIST;DAVINCI SI
• 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: 10609467
• MDR Text Key: 209272943
• Report Number: 2955842-2020-11002
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111543
• UDI-Public: (01)00886874111543(10)N10161026
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050369
• 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: 05/25/2018

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: 420184-11
• Device Catalogue Number: 420184
• Device Lot Number: N10161026 213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• 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
• Patient Age: 57 YR