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

Model Number 470183-14

Device Problems No Device Output (1435); Smoking (1585)

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

Event Date 11/12/2021

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 investigations replicated/confirmed the customer reported complaint of "the doctor started to use the hook cautery and it started to smoke from the portion where the cables are exposed." the instrument was found to have thermal damage at the weld on the monopolar yaw pulley.The root cause of this failure was attributed to device design.Additional observations not reported by site but related to the reported event were identified.The instrument was disassembled for further inspection during in-house testing.The instrument was found to have thermal damage on the conductor cap.The root cause of this failure was attributed to a component failure.The instrument was found to have a broken conductor wire at the weld of the distal assembly.The instrument failed the electrical continuity test and thermal damage was observed at the weld.The root cause of this failure was attributed to device design.The instrument was found to have thermal damage of the conductor wire¿s insulation at the distal assembly.As a result, the conductor wire was exposed.The root cause of this failure was attributed to a component failure.A review of the site's complaint history does not show any additional complaints related to this product.No image or video clip for the reported event was submitted for review.A review of the instrument log was performed.The instrument was last used on (b)(6) 2021 on system sk1964.The permanent cautery hook had 0 uses remaining out of 10 total uses after the last use.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the permanent cautery hook instrument started smoking from the portion where the cables were exposed.Based on failure analysis investigation there was evidence of thermal damage to the weld with no indication or claim of user mishandling or misuse.Failure analysis also found a damaged/broken conductor wire that has 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.Blank mdr field information: follow-up was attempted, but the patient information for blank fields was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is not applicable because the product is not implantable.Initial reporter also sent report to fda? is blank because it is unknown if the initial reporter.Submitted a report to the fda.Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure when the doctor started using the permanent cautery hook, the instrument started smoking from the portion where the cables were exposed.The surgeon immediately stopped cauterizing and tried to cauterize again to see where the smoke was coming from and it was smoking from the same location.The surgeon inspected the liver bed where he was working for any sign of injury and did not find any.The instrument was handed off and a new one was opened.The procedure was completed 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.The technician noticed something on the "yellow" portion when the tip was bent 90-degrees.The cannula and a pin gauge were inspected prior to use.The staff was using coag when smoke was seen.The customer was using the hook on the gall bladder to remove from the liver.The settings were set for cut 3 and coag 3.The customer was using fenestrated bipolar forceps during the event.The instrument did not collide with any other instrument or tool.The hook was not immersed in liquid or was contaminated by carbonized tissue.The customer did not return to the hospital due to experiencing any post-surgical complications as a result of smoking.The instrument is available for return to isi for evaluation.

• 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: 12974637
• MDR Text Key: 282030046
• Report Number: 2955842-2021-11707
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(10)N10190930
• 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: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• 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: N10190930 0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2019
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White