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

Model Number 470183-14

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

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

Event Date 02/21/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the robotics coordinator (roco) called an intuitive surgical, inc.(isi) technical support engineer (tse) to report that the surgeon stated there was smoke coming from the wires near the base of the tip of the permanent cautery hook instrument.The surgeon noticed this while they were removing the gallbladder and only had a short amount left to remove.They noticed it because they were getting a good amount of smoke.Roco stated that the customer did not note anything frayed or broken on the instrument.The instrument worked fine and since the issue was not noticed until the gallbladder was almost out, so the instrument was not removed.Roco stated that the customer was able to complete the procedure with the same instrument and did not have any additional issues during the procedure.Tse viewed live logs and found no relevant errors.Tse recommended returning the instrument for failure analysis.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the instrument was inspected.There was no visual damage to the instrument.The surgical task involved was cauterizing and dissecting.Monopolar coagulation energy was used.The monopolar cord was not connected to the bipolar instrument.The erbe generator was used.The settings were 4 for cut and 4 for coagulation.There was no instrument collision.There was no arcing involved.The instrument was making a smoke plume near the cables when the energy was activated.The surgeon noted it was smoking a lot, not at the tip but at the cables.It worked fine and was not noticed until almost to the end of the procedure.This event occurred on the first use of the instrument.The procedure was completed with no injury to the patient.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook instrument associated with this complaint and completed its investigation.The failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary finding of yaw pulley thermal damage to be related to the customer reported complaint.One of the distal clevis ears were cut off to inspect the conductor wire.The conductor wire was found to be damaged at the weld causing the thermal damage on the yaw pulley and conductor wire cap.The electrical continuity test failed.The root cause of this failure is a device design failure.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was submitted for review.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.Per system logs the permanent cautery hook instrument associated with this event was last used on (b)(6) 2022 on system (b)(4).The instrument had 7 uses remaining.This complaint is being classified as a reportable event due to the following conclusion: there was evidence of thermal damage to the weld.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.

• 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: 13865356
• MDR Text Key: 287771245
• Report Number: 2955842-2022-10722
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)211028(10)N12211101
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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: N12211101 0104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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
• Patient Age: 38 YR
• Patient Sex: Female