MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER EXTEND

Model Number 480422-01

Device Problem Energy Output Problem (1431)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse was unable to replicate the reported complaint.The fse replaced the e-100 generator at the request of the customer due to the sealing issue that was reported, despite no issue being identified.The system was tested and verified as ready for use following replacement of the generator.Isi received the e-100 generator involved with this complaint and completed the device evaluation.Failure analysis investigation did not confirm/replicate the reported complaint.The unit was tested with a saline dipped gauze.The energy was activated 100 times without finding any issues.There was no problem detected with the e-100 generator.The vessel sealer extend instrument that was used during the procedure was discarded and it will not be returned for a failure analysis.A review of the site's complaint history found no other complaints for the vessel sealer extend instrument.No image or procedure video was provided for review.A review of the instrument log for the vessel sealer extend instrument (part number: 480422-01, lot number: m90210527-0059) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021 on system (b)(4).The instrument was used for 24 minutes.A review of the e-100 generator log associated with this event has been performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The following additional information was provided: ¿there were 7 procedures across the 3 reported event dates: 3 procedures on (b)(6), 1 procedure on (b)(6), and 3 procedures more on (b)(6).The only messages stored from the e-100 across these 7 procedures were ¿high initial starting impedance¿ messages.These messages indicate that the impedance of the tissue between the jaws was detected as higher than anticipated by the generator.This does not indicate an instrument failure- this message is more due to clinical reasons, such as sealing over dried out/desiccated tissue, sealing over too much tissue, sealing in the same location multiple times, etc.Additionally, the generator was returned as rma (b)(4)- the generator passed post (power on self-test) and no issues were found with the generator.¿ this complaint is reportable due to the following: the vessel sealer extend instrument used with the e-100 generator reportedly was not sealing completely, even though the generator provided the appropriate audible tones during the seal cycle and upon completion of the seal cycle.Deficiencies in sealing may lead to inadequate hemostasis.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 surgical procedure, the surgeon stated the vessel sealer extend (vse) instrument which was in use with the e-100 generator was not sealing completely.The procedure was completed with no reported patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter, a nurse, on 23-sep-2021 and obtained additional information: the vse instrument sealed tissue; however, the surgeon was not happy with the strength of the cautery energy coming from the e-100 generator.The surgeon continued using the vse instrument and resealed any area of bleeding with the vse instrument until hemostasis was achieved.The surgeon was using both seal and bipolar modes on the vse instrument.On 08-oct-2021, isi followed up with the initial reporter again and obtained additional information.The instrument was inspected prior to use and no damage was noted.During some sealing attempts, the tissues were not sealed and the surgeon had to use bipolar mode of the vse instruments to address bleeding/oozing of the tissues.The amount of bleeding was noted as "minimal." the surgeon heard the continuous audible tone during the sealing sequence and the seal completion tone indicating the seal was completed.Tissue effect was observed during the sealing cycle.The target tissue was uterus, less than 7mm in diameter, with no evidence of calcification, and no previous exposure to radiation or chemotherapy.The surgeon continued to use the same vse instrument and the same e-100 generator the rest of the procedure, which was completed with no reported patient injury.The vse instrument was discarded after the procedure and therefore is not available to be returned for analysis.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 12686778
• MDR Text Key: 282344518
• Report Number: 2955842-2021-11371
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)M90210527
• Combination Product (y/n): N
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: M90210527 0059
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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