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

Model Number 470183-14

Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Arcing (2583)

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

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.The instrument was found to have a broken conductor wire at the weld joint of the yaw pulley after one side of the clevis ear was removed for further investigation.The silicone potting appear to be compromised and the conductor wire thermally damaged around the weld location.Any material missing is likely to be thermally induced rather than mechanically induced.Failure analysis found the primary failure of broken conductor wire at the weld to be related to the customer reported complaint.Root cause is attributed to a device design.Additional observation not reported by the site was that the instrument was found have thermal damage of the monopolar yaw pulley.Black char marks were observed.Any material missing is likely to be thermally induced rather than mechanically induced.Failure analysis found the additional failure of thermal damage of the monopolar yaw pulley-weld damage to be related to the customer reported complaint.Root cause is attributed to a device design.A site history complaint review was performed and no related complaints were found to the product.A system log review confirmed the permanent cautery hook was last used on (b)(6) 2021 on (b)(4) with 4 uses remaining.The permanent cautery hook is intended to be used with the da vinci system for precise dissection and division of tissue with monopolar cautery.The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console (ssc).This complaint is reportable due to the following conclusion: there was evidence of thermal damage to the weld with no indication 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 the permanent cautery hook instrument caught on fire and smoked during a da vinci-assisted cholecystectomy surgical procedure.The procedure was completed with no patient harm.Intuitive surgical inc.(isi) followed up with the customer and obtained the following additional information on 28-june-2021.It was confirmed that there was no patient harm, including no harm to the surround tissue.The customer clarified that by "fire" they meant that they saw sparks coming from the instrument.A replacement cautery hook instrument was used to continue and complete the procedure.No other details related to the event and no patient-related information was available.

• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12204038
• MDR Text Key: 262692197
• Report Number: 2955842-2021-10836
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)201217(10)N10210104
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• 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: N10210104 0178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Date Manufacturer Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• 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