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

Model Number 470183-14

Device Problems Break (1069); Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2021

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the customer reported complaint.Failure analysis found the primary finding of ceramic sleeve broken to be related to the customer reported complaint.The instrument was found to have a broken ceramic sleeve with no missing pieces.The root cause of broken instrument ceramic sleeve is typically attributed to mishandling / misuse, such as excess force applied to the distal end of the instrument or accidental collisions.Additional finding related to the customer reported complaint was thermal damage located where the ceramic sleeve broke off.The root cause of this failure is attributed to device design.A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.No image or procedure video was provided.A review of the instrument log for the permanent cautery hook instrument (pn# 470183-14 / lot# n10210426-0191) associated with this event has been performed.Per logs, the instrument was last used on 11/24/2021 on system (b)(4) for approximately 30 minutes.The alleged event occurred on the 8th use of the instrument with 2 lives remaining.This complaint is being reported due to the following conclusion: there was evidence of thermal damage proximal to the ceramic sleeve.Thermal damage proximal to where the ceramic sleeve broke off 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.

Event Description

It was reported that during a da vinci-assisted abdominoperineal resection surgical procedure, black insulation on the permanent cautery hook instrument was found to be loose and insulation on the tip of the cautery broke off and fell into the patient.The fragment was removed during the same procedure and the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter for additional information; however, no response has been received at this time.

Manufacturer Narrative

Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.Corrected information can be found the following field: b1, b2, and h1: b1 updated from "product problem" to "adverse event and product problem".B2 updated to "required intervention".H1 updated from "malfunction" to "serious injury".

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY HOOK
• 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: 13259171
• MDR Text Key: 294165723
• Report Number: 2955842-2022-10066
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)210422(10)N10210426
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: N10210426 0191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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