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

Model Number 470183-14

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) replicated and confirmed the customer reported complaint that the permanent cautery hook had a broken tip.Fa found the primary of broken proximal clevis to be related to the customer reported complaint.The instrument was found to have the plastic proximal clevis broken.One of the ears of the clevis was broken off and was not returned with the instrument as a result of breakage.The size of missing piece is approximately 0.144¿ x 0.188¿ in length.No cable/wire damage or missing pins were observed.No thermal damage was found.The root cause of broken instrument proximal clevis is typically attributed to mishandling/misuse, such as excess force applied to the distal end of the instrument.A review of the procedure log showed the permanent cautery hook (part# 470183-14 / lot# n10190514 0116) was last used on (b)(6) 2022 on system sk1508.The instrument had 7 lives remaining.This complaint remains a reportable event due to the following conclusion: failure analysis confirmed the instrument's clevis was missing.This instrument is designed with a clevis pin on the distal end allowing articulation of the instrument assemblies they are holding together and is secured to the device by swaging.If the pin is not properly fused together, the pin could become dislodged and fall into the patient.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 prior to the start of a da vinci-assisted surgical procedure, the permanent cautery hook had a broken tip.A backup instrument was used.The device was not used on the patient.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 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: 14973739
• MDR Text Key: 303955615
• Report Number: 2955842-2022-12885
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(10)N10190514
• 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
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: N10190514 0116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES