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

Model Number 480422-01

Device Problems Difficult to Remove (1528); Defective Device (2588); Difficult to Open or Close (2921)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

The vessel sealer extend involved in this event has not yet been returned for analysis.Site history review: a review of the site's complaint history does not show any additional complaints related to this product and/or this event.Image/video review: no image or video was provided.System log review/product and event verification: a review of the instrument log for the vessel sealer extend associated with this event has been performed.Per logs, the vessel sealer extend was last used on (b)(6) 2020 on system (b)(4).The instrument is a single-use instrument.The logs indicate the user pressed the emergency stop button (error 256) to address the issue with the stapler instrument.Technical support engineer (tse) reviewed system logs and confirmed 22025 informational errors indicating the instrument blade was jammed.The vessel sealer extend is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.When functioning properly, the instrument has both visual (tissue effect) and audio (tones from the generator) cues that provide feedback to the user that it is operating as intended.Based on the information provided at this time, this complaint is a reportable event due to the following conclusion: the vessel sealer extend complaint alleges the grips did not open after it had been working.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 vessel sealer extend instrument stopped working and was stuck on tissue.Prior to calling technical support, the surgeon pressed the emergency stop (e-stop) and was able to successfully remove the vessel sealer extend instrument when it was unable to disengage.The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed system logs and confirmed 22025 informational errors for the instrument blade, unable to retract on patient cart control & transform processor (pctp).The site recovered from the fault and installed a backup vessel sealer extend to proceed with the case as planned.There was no report of patient injury.

Manufacturer Narrative

D15, d11 - intuitive surgical, inc.(isi) received the vessel sealer extend associated with this complaint and completed its investigation.Failure analysis (fa) did not confirm he customer reported issue that the "vessel sealer clamped to tissue and was unable to disengage." fa noted functional testing of the device in an attempt to replicate the report complaint is not possible due to the returned condition of the device.There were additional observations not reported by site that is not related to the customer reported complaint that fa identified: the instrument was found to have a self test homing failure during in-house testing.After opening the housing, the blade could not be extended to inspect for any damage to the blade or knife cable.The instrument was found to have a dislodged blade based on log review and fa found no conductor wire damage or snake wrist damage.There was significant bio debris found at the instrument tip and the instrument passed the knife slot test.Fa found no ceramic dots missing and a review of the system event logs showed only 1 blade exposed failure.Additional investigation was performed by advanced failure analysis (afa) and the following was noted: afa was unable to test instrument on an in-house system, as the blade was not able to extend.The instrument knife cable was found to be damaged inside the back end, just after the knife cover.This component failure of the knife cable likely occurred during the failed in-house homing attempts, as the knife blade was stuck.There was heavy bio-debris found at the distal end of the instrument.Extracting the instrument blade required complete instrument disassembly and the knife cable was found to have heavy bio-debris towards the distal end, indicating the stuck blade was likely due to dried bio-debris.Relating to the customer complaint, the grip input and the jaws of the instrument were fully functional when tested off the system (manual articulation, emergency release & manual articulation of input discs).

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10955719
• MDR Text Key: 234112377
• Report Number: 2955842-2020-11311
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)M90200721
• Combination Product (y/n): N
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2020
• 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: M90200721 0235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.