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

Model Number 420183-15

Device Problems Break (1069); Melted (1385)

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

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported failure.The instrument was tested for electrical continuity and failed.The ear of the distal clevis was cut for inspection and the instrument conductor wire was found broken at the weld.Upon visual inspection, localized melting/arcing was observed on the monopolar yaw pulley, conductor cap, proximal idler pulley, and the proximal clevis as a result of conductor wire weld damage.A review of the instrument log for the permanent cautery hook (part # 420183 / lot # n10190513 083) associated with this event has been performed.Per logs, the permanent cautery hook was last used on (b)(6) 2020 on system (b)(4), with 4 lives remaining.A review of the site's complaint history showed no additional complaints related to this product.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported because the instrument's conductor wire was broken at the weld with no evidence or claim of user mishandling or misuse.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.

Event Description

It was reported that during a da vinci-assisted surgical procedure, there was no energy coming to the instrument.The customer replaced the monopolar cord, but the issue persisted.A similar backup da vinci instrument was used to continue with the case.The procedure was completed with no reported injury.

• 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: 10702225
• MDR Text Key: 242236190
• Report Number: 2955842-2020-11098
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)N10190513
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420183-15
• Device Catalogue Number: 420183
• Device Lot Number: N10190513 083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2019
• 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
• Patient Age: 52 YR