MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; FENESTRATED BIPOLAR FORCEPS

Model Number 420205-12

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps for failure analysis investigation, however, the investigation is still in progress.Therefore, the root cause of the customer reported failure has not been determined.A follow-up mdr will be submitted to the fda once the failure analysis investigation has been completed and/or if additional information is received.A review of the instrument log for the fenestrated bipolar forceps (420205-12/n10190311 738) was performed.The instrument was last used on (b)(6) 2020 on system sh2395.There is no indication that the instrument was used in subsequent procedures after the alleged event reported on this record.A failure analysis engineer (fae) has been requested to review the submitted image(s).At this time, the investigation has not been completed.A review of the site's complaint history does not show any additional complaints related to this product.Based on the information provided at this time, this complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, smoke was observed from an unintended location on the instrument.Although no patient harm was reported, if this malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, smoke was coming from the joint of the instrument when the surgeon was coagulating the tissue.The customer alleged the joint was scabbed.The bipolar power setting of forcetriad was 40 watts.The instrument was replaced.There was no report of fragment(s) falling inside the patient.The procedure was completed with no reported patient harm, adverse outcome, or injury.Intuitive surgical followed up with the customer and obtained the following additional information: there was no damage noted on the instrument prior to use.It is unknown if arcing of electrical energy was observed during the surgical procedure.The monopolar cord was not connected to the bipolar instrument.The customer alleged the monopolar curved scissors was in use when the event occurred.There was no report of instrument collision.After the instrument occurred, the instrument was removed.The patient has not returned to the hospital due to experiencing any post-surgical complications.No video recording of the procedure is available.There is no information pertaining to patient demographics nor tests or laboratory data that were performed specific to the incident.

Manufacturer Narrative

A review of the submitted images was performed by a failure analysis engineer (fae), and it was noted that the instrument displayed thermal damage between the grips.The thermal damage is most commonly caused by insulation degradation and carbonized tissue creating a conductive path in which energy can travel and cause thermal damage.61 - intuitive surgical received the fenestrated bipolar forceps involved with this complaint and completed the device evaluation.The reported complaint was confirmed during failure analysis.The instrument was found to have charring and localized melting at the grip base between the grips.This failure is most commonly caused by insulation degradation and carbonized tissue creating a conductive path.The instrument passed the electrical continuity test.Based on the failure analysis results, the initial mdr report is being retracted as the damage to the instrument was found to be due to mishandling/misuse and not due to a malfunction of the unit.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Refer to the following field for corrected information: b3 (event date).Refer to the following fields for updated information: g3, g6, h2, and h10.The event date has been corrected from (b)(6) 2020 to (b)(6) 2020.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10370765
• MDR Text Key: 201822806
• Report Number: 2955842-2020-10717
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111642
• UDI-Public: (01)00886874111642(10)N10190311
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420205-12
• Device Catalogue Number: 420205
• Device Lot Number: N10190311 738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES