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

Model Number 420205-16

Device Problem Arcing (2583)

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

Event Date 02/18/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted malignant hysterectomy surgical procedure, a spark was observed from the fenestrated bipolar forceps instrument and afterwards they stopped energizing.A backup instrument of the same type was used to continue the procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: the instrument and cannula were inspected prior to use with no issues identified and no damage was noted to the instrument after a spark was observed approximately 120 minutes into its use.It was unknown where the spark originated.The instrument was using bipolar energy to cauterize tissue with both cut and coagulation settings of 30.No interoperative collisions or contact with staples, clips, or sutures were observed.The spark occurred while the instruments tips were in contact with tissue.The instrument jaws were not immersed in liquid or contaminated by carbonized tissue and the instrument was not removed from the patient prior to the arcing event.The patient harm was reported and has not returned to the hospital experiencing any post-surgical complications.The instrument is available for return for evaluation.Photographic images of the device or a video recording of the procedure are available for isi review; however, they have not been provided as of this report.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested the fenestrated bipolar forceps instrument for evaluation, but the instrument has not yet been received as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned for analysis and/or if additional information is received.A review of the logs showed the fenestrated bipolar forceps instrument (pn# 420205-16 lot# n10210607-873) was last used on (b)(6) 2022 on system (b)(4) for approximately 1 hours and 3 minutes.The alleged event occurred on the 7th use of the instrument.In addition, a review of the site's complaint history does not show any additional complaints associated with or related to the reported fenestrated bipolar forceps lot number.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 arced during the procedure.The allegation could be related to the 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.

Manufacturer Narrative

Additional information can be found in the following fields: d9, g3, g6, h2, and h3.Failure analysis investigation can be found in the following fields: h6 and h10.Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of the thermal damage to the bipolar yaw pulley between the grips, to be related to the customer reported complaint.The fenestrated bipolar forceps instrument was found to have charring and localized melting at the grip base between the grips.The instrument passed the electrical continuity test and no damage found to the conductor wire.The root cause of the thermal damage between grips instrument bipolar yaw pulley is typically attributed to mishandling/misuse, most commonly caused by the insulation degradation and carbonized tissue creating a conductive path.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• 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: 14101024
• MDR Text Key: 298668807
• Report Number: 2955842-2022-11019
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111642
• UDI-Public: (01)00886874111642(10)N10210607
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• 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: N10210607 870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2021
• 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 Sex: Female