MAUDE Adverse Event Report: ENDOWRIST;DAVINCI SI; FENESTRATED BIPOLAR FORCEPS

Model Number 420205-16

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 07/31/2021

Event Type  malfunction  

Manufacturer Narrative

The fenestrated bipolar forceps instrument has not been returned to isi for evaluation.Therefore the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.A review of the instrument log for the fenestrated bipolar forceps instrument (pn# 420205-16 lot# n10201214-272) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021 on system (b)(4) for approximately 30 seconds.The alleged event occurred on the 7th use of the instrument.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: it was alleged that the instrument sparked and exhibited signs indicative of thermal damage with no evidence or claim of user mishandling or misuse.At this time, it is unknown what caused the thermal damage to occur.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 pulmonary decortication surgical procedure, the fenestrated bipolar forceps instrument sparked in the cavity and melted the plastic part during the procedure.A backup instrument of the same type was used and the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up on 13-aug-2021 and obtained the following additional information: the instrument was inspected prior to use and there was no damage.The instrument did not collide with any other instrument or tool during the procedure.It is unknown how long the instrument was in use prior to the arcing event.There was no injury to the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications as a result of the arcing event.No images or video are available for isi review as they are confidential.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

D11 - intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis found the primary failure of bipolar yaw pulley thermal damage between grips to be related to the customer reported complaint.The instrument was found to have charring and localized melting at the grip base between the grips.The instrument passed the electrical continuity test.No damage to the conductor wire was observed.This failure is most commonly caused by insulation degradation and carbonized tissue creating a conductive path.The instrument passed the electrical continuity test.Root cause is attributed to mishandling/misuse.Based on the failure analysis results, the damage to the instrument was found to be due to mishandling/misuse and not due to a malfunction of the instrument.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• MDR Report Key: 12427186
• MDR Text Key: 270036217
• Report Number: 2955842-2021-11081
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111642
• UDI-Public: (01)00886874111642(10)N10201214
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420205-16
• Device Catalogue Number: 420205
• Device Lot Number: N10201214 272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• 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