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

Model Number 480422-01

Event Date 03/21/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted malignant hysterectomy surgical procedure, the vessel sealer extend instrument had an exposed blade.There was no report of injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: a backup instrument was used to complete the procedure.No further information was provided.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the vessel sealer extend instrument associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint.Failure analysis found the primary failure of failure during initialization to be related to the customer reported complaint.For clarification, the instrument was found to have initialization failures based on log review and during in-house testing.A review of the logs showed 2 homing failures during initialization.The instrument was placed on an in-house system and failed to initialize during self-test.An error stating ¿self test failed.Remove instrument warning: blade may be exposed¿ appeared.Upon visual inspection, there was no exposed blade upon return and during testing.The jaw ceramic dots were present and no damage was observed at the distal wrist.Additional observations related to the customer reported complaint: the homing failures were manually overridden in-house and the instrument was retested.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests but failed to move intuitively.The grip was not following the master tool manipulator input commands smoothly.The wrist moved intuitively but remained open and failed to close on command.When the grip open lever was used, the grip opened but failed to close completely.This failure likely caused the homing failures.The root cause is not determinable/applicable and was transferred to engineering.Failure analysis engineer confirmed the primary failure analysis.When the instrument was placed on in-house system, the instrument failed the initialization test due to an expose blade.After removing the housing it was discovered that the washer on top of the grip ring was dislodged due to the c-ring also being dislodged.This dislodgement of the c-ring prevents the grip tube from returning to the "jaws closed" position, thus leaving the jaw open.The open jaw in turn prevents the blade from returning back into the garage while performing the initialization test.The c-ring dislodgement is due to a manufacturing related error.No image or video was provided for review.A review of the instrument log for the vessel sealer extend instrument (part# 480422-01/lot# m90210907 0032) associated with this event has been performed.Per logs, the instrument was used for a procedure on (b)(6) 2022 using system (b)(4).This complaint is being reported based on the following conclusion: failure analysis confirmed the endowrist vessel sealer extend instrument has a component failure that would not allow for the grips to open with use of grip release.Medical intervention may be required in the event that the endowrist vessel sealer extend instrument fails to unclamp from tissue when commanded by the user or system.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.If additional information becomes available, the complaint will be re-evaluated.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• 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: 15090465
• MDR Text Key: 304633689
• Report Number: 2955842-2022-13126
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)M90210907
• Combination Product (y/n): N
• PMA/PMN Number: K173337
• 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: 06/23/2022

1 Device 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: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: M90210907 0032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• 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