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

Model Number 470183-14

Device Problems Thermal Decomposition of Device (1071); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook involved with this complaint and completed the instrument evaluation.Failure analysis investigations confirmed the customer reported complaint.Failure analysis found the primary failure of dislodged ceramic sleeve.The instrument was found to have a dislodged ceramic sleeve.No missing material was found.The root cause of dislodged instrument ceramic sleeve is attributed to manufacturing.Additional observation related to the customer reported complaint: the instrument was found to exhibit sleeve thermal damage on the monopolar yaw pulley.The thermal damage was located at the top of the yaw pulley as a result of the dislodged ceramic sleeve.Electrical continuity was tested and passed.The root cause is attributed to a device design.A review of the site's complaint does not show any additional complaints related to this product and/or this event.A review of the instrument log for part# 470183-14/lot# n10210222 0023 associated with this event has been performed.Per logs, the permanent cautery hook was last used on (b)(6) 2022 on system sk4404 with 4 lives remaining.The review of provided image confirmed the customer reported complaint of dislodgement of ceramic sleeve.Based on the additional information obtained from failure analysis investigation, this complaint is being reported due to the following conclusion: there was evidence of thermal damage on the monopolar yaw pulley of the ceramic sleeve.Thermal damage on the monopolar yaw pulley of 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 was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that during pulmonary lobectomy da vinci-assisted surgical procedure, the black ring connector of permanent cautery hook was prolapsed.Backup instrument of same kind was used to complete the procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer to obtain the information regarding patient demographics, relevant testing, and medical history; however, the customer was not able to provide that information.Per customer, the permanent cautery hook was inspected prior to use and no anomaly was noted.There was no report of any collision or arcing.

• 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: 14247674
• MDR Text Key: 290364253
• Report Number: 2955842-2022-11314
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)210218(10)N10210222
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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: N10210222 0023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• 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.