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

Model Number 480440-06

Device Problems Thermal Decomposition of Device (1071); Failure to Deliver Energy (1211)

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

Event Date 08/08/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the synchroseal instrument involved with this complaint and completed the device evaluation.Failure analysis was unable to replicate nor confirm the reported complaint.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.Energy delivery with coagulation and sync functioned properly, and continuity test was performed and passed.The jaw verification was performed and passed within specification.The grip force test passed with the straight orientation at 4.997 lbs.Visual inspection was performed and all 9 ceramic dots were present.The instrument was fully functional.The error logs did not show any failures.As part of investigation, inspection found thermal damage on the cut electrode on the jaw.The instrument was subjected to a 2nd electrical continuity test and passed.The root cause of this failure is attributed to a component failure.An advanced failure analysis engineer further investigated the instrument and confirmed that the seal functionality was utilized successfully after each attempt.Fae noted that instrument was functional.Instrument.The e-100 logs were checked, and there were no errors that would indicate that the instrument would not seal properly.The seal function was utilized multiple times, and no error occurred during any attempt.No image or procedure video was provided for review.A review of the device logs for the synchroseal instrument (part# 480440-06| lot/serial# (b)(4)) associated with this event has been performed.Per logs, the synchroseal instrument was last used on (b)(6) 2022 via system serial# (b)(4).There were 0 uses remaining after this last usage.Based on the additional information, this complaint is considered a reportable event due to the following conclusion: there was evidence of thermal damage on the cut electrode on the jaw.Thermal damage on the cut electrode is evidence of 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.

Event Description

It was reported that during a da vinci-assisted nephrectomy surgical procedure, a customer reported that the synchroseal instrument stopped / failed to energize after three or four uses.Use of the instrument was discontinued and the instrument was replaced to the backup.The user continued the procedure with no further issues and no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use.The instrument did not work.Am error occurred when the synchroseal sealing issue occurred, but the customer was unable to recall the specific error message.The target tissue at the time of the issue was fatty tissue and there was no unexpected bleeding.

• Brand Name: DA VINCI ENERGY
• Type of Device: SYNCHROSEAL
• 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: 15656383
• MDR Text Key: 302241907
• Report Number: 2955842-2022-14786
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(17)240131(10)L90220131
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480440-06
• Device Catalogue Number: 480440
• Device Lot Number: L90220131 0147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• 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