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

Model Number 470183-14

Device Problems Thermal Decomposition of Device (1071); No Apparent Adverse Event (3189)

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

Event Date 08/12/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the distal tip of 8mm, permanent cautery hook instrument was burnt.The procedure was completed using a backup instrument with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use, and nothing was observed out of the ordinary.The cannula was inspected prior to use and a gage pin was used to inspect the canula.The surgical task being performed was cautery.A monopolar cord was not connected to a bipolar instrument.The erbe was the type of generator/electrosurgical unit (esu) that was used.The patient has not returned to the hospital and has not experienced any post-surgical complications.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the evaluation.Failure analysis confirmed and replicated the reported complaint.Investigation found thermal damage on the monopolar yaw pulley.The distal end was disassembled in house and no damage to the conductor wire, the conductor cap and the ceramic sleeve was observed.Electrical continuity was performed and passed.Additionally, further inspection identified thermal damage on the distal clevis.This observation is related to the thermal damage on the monopolar yaw pulley.The root cause of these failures is attributed to instrument mishandling and misuse.A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.A review of the device logs for the permanent cautery hook (part #470183-14 | lot #k11220517-0176) associated with this event has been performed.Per this review, the permanent cautery hook was last used on (b)(6) 2022 via system serial #(b)(4).There were 5 uses remaining after this last usage.This last usage of the device was before the reported event date, indicating that the device did not pass recognition, or the issue was identified before installation on the reported event date of (b)(6) 2022.This complaint is considered a reportable malfunction due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.Failure analysis confirmed thermal damage to the monopolar yaw pulley that is indicative of instrument mishandling and 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.

• 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: 15397904
• MDR Text Key: 299657327
• Report Number: 2955842-2022-13947
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)220512(10)K11220517
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2022
• 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: K11220517 0176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2022
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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