MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENERGY; SYNCHROSEAL

Model Number 480440-05

Device Problem Power Problem (3010)

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

Event Date 09/26/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the clinical sales representative (csr) called in stating that the e-100 generator powered off while using a synchroseal instrument.The e-100 generator was powered on again, and the issue was resolved.The csr found no damage on the synchroseal ¿s jaw.The suspected cause of the issue was due to arcing.The procedure was continuing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the synchroseal instrument was visually inspected prior to use with no damage observed.The instrument worked for about 3 to 4 hours and sealed tissue at the time of the event.It displayed sync mode when sealed and the jaw was closed.When the surgeon pressed the yellow pedal again, the message "check that e-100 is powered on, e-100 not detected¿ displayed, and the surgeon noticed the power was off.It was unknown if arcing was observed and if arcing did happen, if it was contained within the jaws of the instrument.The jaws did not come into contact with a clip, suture, staple, or other metal objects.For vascular treatment, the medium-large clip was used in the center while the synchroseal was used for the periphery.The synchroseal was kept away from the clip.The jaws were not immersed in a liquid or contaminated by carbonized tissue (bio debris) prior to or during the sealing cycle.The instrument was discarded and will not be returned for evaluation.Photographic images of the device or a video recording of the procedure were not available for isi review.Information regarding patient demographics, relevant testing, and medical history were requested; however, the reporter was not able to provide that information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the synchroseal instrument for evaluation because the instrument was disposed by the site.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.In addition, a review of the instrument log for the synchroseal instrument (part # 480440-05/ lot # l90210221 0077) associated with this event has been performed.Per logs, the instrument was used on (b)(6) 2021, on system (b)(4).This is a single-use instrument.No image or video clip for the reported event was submitted to isi for review.This event is being reported based on the following conclusion: it was alleged that the instrument may have arced during the procedure with no evidence or claim of user mishandling or misuse.The allegation is 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.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

• Brand Name: DA VINCI ENERGY
• Type of Device: SYNCHROSEAL
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 12679655
• MDR Text Key: 282741755
• Report Number: 2955842-2021-11344
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(17)230228(10)L90210221
• Combination Product (y/n): N
• PMA/PMN Number: K191280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480440-05
• Device Catalogue Number: 480440
• Device Lot Number: L90210221 0077
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES