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

Model Number 470183-14

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 04/04/2022

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) has received the pch instrument associated with this complaint and completed investigations.Failure analysis investigations replicated/ confirmed the customer reported complaint.Failure analysis found the primary failure of the thermal damage on the monopolar yaw pulley to be related to the customer reported complaint.The pch instrument was found to have thermal damage on the yaw pulley.The root cause of this failure is attributed to device design.Additional findings not reported by site were also identified: the pch instrument was found to have the conductor wire broken at the weld.As a result, the instrument failed the electrical continuity test.The root cause of this failure is attributed to device design.The instruments conductor wire cap was found to have thermal damage.The root cause of this failure is attributed to mishandling/misuse.The instrument was found to have an excessive amount of dried residue around the clamping pulley cable grooves.The root cause of the residue on the instrument clamping pulleys is typically attributed to mishandling/misuse, most commonly caused by improper cleaning/reprocessing techniques, such as insufficient flushing.Signs of corrosion/contamination were found on the pch instrument bearings.The pitch/grip input disk bearings exhibited orange discoloration.The root cause of the corroded/contaminated instrument bearings is typically attributed to mishandling/misuse, most commonly caused by improper cleaning/reprocessing techniques.No image or video was available for review.A review of the instrument logs for the pch instrument (part number 470183-14/lot number n11201123 0026) associated with this event has been performed.Per the review, the pch instrument was last used in a procedure on (b)(6) 2022 on system (b)(4).The alleged instrument had 4 uses remaining after the last procedural use.This complaint is reportable malfunction event due to the following conclusion: it was alleged that the pch instrument had evidence of thermal damage at the tip.The allegation could be related to the potential for 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.

Event Description

It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the permanent cautery hook (pch) instrument had thermal damage at the tip housing and the customer did not feel safe using it.The procedure was completed with no reported injury.The permanent cautery hook (pch) 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).Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the permanent cautery hook instrument damage was noted during procedure.It is unknown if the instrument was inspected prior to use.There was no arcing observed during procedure and the issue was resolved using back up instrument.

• 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: 15160751
• MDR Text Key: 297206709
• Report Number: 2955842-2022-13325
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)201120(10)N11201123
• Combination Product (y/n): N
• 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: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• 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: N11201123 0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• 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