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

Model Number 480440-06

Device Problems Thermal Decomposition of Device (1071); Entrapment of Device (1212)

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

Event Date 02/17/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations did not replicate nor confirm the customer reported complaint.The synchroseal instrument passed recognition/engagement tests, but failed the homing self-test.During testing, the instrument moved intuitively with full range of motion in all directions.The instrument grips opened/closed properly and also passed the electrical continuity, energy delivery, cut, jaw gap verification and grip force tests.The energy delivery test was performed with various orientations of the grip tips and passed for both sync and seal function.Fa found no ceramic dots missing.Furthermore, fa reviewed the instrument logs and found no related errors.Additionally, fa found thermal damage to the cut electrode of the grip tips, which fa attributed to a component failure.Advanced failure analysis (afa) was performed on 8/30/2022 and the following was verified: the instrument was placed on an in house system and passed the recognition, engagement, self-test, and energy delivery test multiple times.The instrument e-100 logs were checked and there was one instance of a cut electrode shorted error, however the user was able to cut and seal after this error occurred.A review of the device logs for the 8 mm synchroseal (part# 480440-06 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the synchroseal was last used on (b)(6) 2022 during a mediastinal mass resection procedure via system serial# (b)(4).This complaint is a reportable event due to the following conclusion: it was reported that tissue was sticking to the instrument's grips.Medical intervention may be required in the event the instrument entraps tissue and causes damage.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 mediastinal mass resection surgical procedure the synchroseal instrument failed during use and was sticking to tissue.The procedure was completed with no reported injury.Synchroseal is a bipolar electrosurgical instrument for use with a compatible da vinci surgical system and a compatible electro surgical generator.It is intended for grasping, dissection, sealing and transection of tissue.Synchroseal can be used to seal vessels up to and including 5 mm in diameter and tissue bundles that fit in the jaws of the instrument.Synchroseal, when used with a compatible electrosurgical generator, creates a seal and transects tissue by application of radiofrequency (rf) energy to vessels and tissue bundles that fit in the jaws of the instrument.Electrode sealing surfaces and a cut electrode within the jaws enable sealing and cutting.Intuitive surgical, inc.(isi) made several attempts to obtain additional information from the customer concerning the reported event with no success.

• 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: 15533434
• MDR Text Key: 301074080
• Report Number: 2955842-2022-14377
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(17)231231(10)L90211212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: L90211212 0120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2021
• 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