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

Model Number 470183-14

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the 8mm permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of ceramic sleeve dislodged to be related to the customer reported complaint.The permanent cautery hook instrument was found to have a dislodged ceramic sleeve.No missing material was found and the root cause of the dislodged ceramic sleeve of the instrument is attributed to manufacturing.Additional observations not reported by the site were also identified.The permanent cautery hook instrument was found to have bent hook tip and the root cause of this failure is attributed to mishandling/misuse.The instrument was found to have thermal damage around the ceramic sleeve area of the monopolar yaw pulley.Root cause of this failure is attributed to device design.A review of the instrument log for the permanent cautery hook (470183-14/n11210412-0035) associated with this event has been performed.Per logs, the permanent cautery hook instrument was last used on (b)(6) 2021 on system sk3887.The instrument had 4 uses remaining after the last procedural use.A review of the site's complaint history does not show any additional complaints related to this product.No image or video was provided for review.This complaint is being reported due to the following conclusion: the permanent cautery hook instrument had thermal damage to the monopolar yaw pulley with no evidence or claim of mishandling or misuse.Thermal damage proximal to the ceramic sleeve 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.Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable.The expiration date for section is not applicable.Field is not applicable because the product is not implantable.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Fields are not applicable.

Event Description

It was reported that after a da vinci-assisted surgical procedure, the 8mm permanent cautery hook instrument did not work.The procedure was completed as planned.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: 13006452
• MDR Text Key: 282255816
• Report Number: 2955842-2021-11746
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)210409(10)N11210412
• 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: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• 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: N11210412 0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• 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