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

Model Number 420205-16

Device Problem Sparking (2595)

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

Event Date 02/16/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted hysterectomy benign procedure, the 8mm fenestrated bipolar forceps instrument was not working properly and sparked.The procedure was completed with a back-up instrument with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 06-mar-2022: the fenestrated bipolar forceps instrument was inspected prior the procedure and it was working fine for 10-15 minutes prior to sparking event.It was noted that the sparking was observed during bipolar function used on the minor vessels.There was no report of instrument collision, and the instrument did not come in contact with staples, clips, or sutures at the time of the event.The bipolar coagulation mode was activated when the sparking event occurred.The force fx was being used during procedure.The fenestrated bipolar forceps instrument jaws were not immersed in liquid or contaminated by carbonized tissue (bio debris) prior to activating the instrument.There was no patient injury and the patient has not returned to the hospital due to experiencing any post-surgical complications as a result of the event.The customer will be returning the instrument for the failure analysis.The patient demographic information was requested, but unavailable.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested the 8mm fenestrated bipolar forceps instrument involved with this complaint to be returned for failure analysis.However, as of the date of this report, the instrument has not been received.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product.No image or video of the last procedure was provided for review.A review of the instrument log for the fenestrated bipolar forceps instrument (420205-16/ n10211018-102) associated with this event has been performed.Per logs, the fenestrated bipolar forceps was last used on (b)(6) 2022 via system (b)(4).The instrument had 6 uses remaining after the last procedural use.This complaint is being reported based on the customer-reported issue as the fenestrated bipolar forceps instrument reportedly sparked.Although there was no patient injury reported as a result of this issue, if the event were to recur, it could cause or contribute to an adverse event.

Manufacturer Narrative

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 investigation confirmed but did not replicate the customer reported complaint.Failure analysis found the primary failure of the thermal damage between grips of the instrument bipolar yaw pulley 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 the root cause of the thermal damage between grips of the instrument bipolar yaw pulley is typically attributed to mishandling/misuse, most commonly caused by 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: 13866026
• MDR Text Key: 296806525
• Report Number: 2955842-2022-10728
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111642
• UDI-Public: (01)00886874111642(10)N10211018
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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: N10211018 102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian