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

Model Number 470184-13

Device Problems Thermal Decomposition of Device (1071); Failure to Deliver Energy (1211); Material Split, Cut or Torn (4008)

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

Event Date 05/10/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, the permanent cautery spatula instrument could not fire.The procedure was completed with no reported injury using a backup permanent cautery spatula instrument.Intuitive surgical, inc.(isi) followed up with the medical engineer (me) and obtained the following additional information: the instrument was inspected prior to use and no issue was found.After sterile reprocessing, the me found the crack visually.It was unknown if instrument collide with any other instrument or tool during the procedure.There was no report on spark of arcing, except for smoke.There was no report of patient¿s impact.Additional information from the respiratory director was obtained: there was a possibility of collision but it was not clear.No arcing was observed during the procedure.The reporter believed collision might have caused the instrument to have broken wire/cable.There was no injury to the patient.The instrument was replaced.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery spatula instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.The instrument was found to have a broken conductor wire at the weld.The instrument failed the electrical continuity test.Thermal damage was observed near the conductor wire-yaw pulley entry.The root cause of this failure is attributed to device design.Additional observations related to the customer reported complaint: the instrument was found to have damage to the conductor wire¿s insulation.The instrument failed the electrical continuity test.The wires were not found to be exposed unless at the location of the wire break.The root cause of this failure is attributed to component failure.In addition, the instrument was found to have thermal damage on the monopolar yaw pulley at the weld.As a result, the conductor wire became broken.The root cause of this failure is attributed to device design.The instrument was also found to have thermal damage on the distal clevis.The root cause of this failure is attributed to the user mishandling/misuse.Additional observation not reported by site: the instrument was found to have various scratch marks removed on the main tube.The scratch marks were 0.088¿ - 0.329¿ in length and were not aligned with the tube axis.The root cause of this failure is typically attributed to mishandling/misuse.A review of the device logs for the permanent cautery spatula (part# 470184-13 | lot/serial# n10210809-0192) associated with this event has been performed.Per this review of the logs, the permanent cautery spatula was last used on (b)(6) 2022 via system (b)(4) for a pulmonary segmentectomy procedure.There were 5 uses remaining after this last usage.No image or video clip for the reported event was available for review.This complaint is considered a reportable event due to the following conclusion: failure analysis found the permanent cautery spatula instrument had conductor wire damage.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.Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Field is blank because the product is not implantable.Information for the blank fields is not available.Fields are not applicable.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY SPATULA
• 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: 15015772
• MDR Text Key: 295892921
• Report Number: 2955842-2022-12951
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112328
• UDI-Public: (01)00886874112328(11)210805(10)N10210809
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470184-13
• Device Catalogue Number: 470184
• Device Lot Number: N10210809 0192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2022
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• 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