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 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.Fa found the primary failure of thermal damage on the monopolar yaw pulley to be related to the customer reported complaint.The instrument was also found to have thermal damage on the distal clevis.No damage to the conductor wire was observed.Electrical continuity was performed and passed.The distal subassembly was disassembled during in-house testing for further inspection.No damage to the ceramic sleeve or the conductor cap was observed.The root cause of this issue is typically attributed to mishandling and misuse.The instrument was also found to have thermal damage on the distal clevis.The root cause of this issue is typically attributed to mishandling and misuse.The ceramic sleeve was not dislodged and did not show any damage.No image or video clip for the reported event was available for review.A review of the instrument log for the permanent cautery hook instrument (part # 470183-14 / lot # k11220208-0065) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2022 via system (b)(4) for a cholecystectomy procedure.There were 5 uses remaining after this last usage and this last usage of the device was before the reported event date.This complaint is being reported based on the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.Failure analysis confirmed thermal damage on the monopolar yaw pulley and distal clevis.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 cholecystectomy surgical procedure, the tip of the permanent cautery hook had thermal damage.There were no other related issues.There was no reported injury to the patient.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information, however, no further details have been received as of the date of this report.

• 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: 14902951
• MDR Text Key: 295219378
• Report Number: 2955842-2022-12786
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)220203(10)K11220208
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2022
• 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: K11220208 0065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• 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