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

Model Number 480422-01

Device Problem Failure to Deliver Energy (1211)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the surgeon stated that the vessel sealer extend cut but did not seal.The surgeon informed the coordinator/rep after learning about the safety alert.The instrument was switched out for another vessel sealer extend, and the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the vessel sealer extend instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.Instrument log review of the product related to the complaint cannot be performed at this time because there is insufficient product information.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: the vessel sealer extend instrument reportedly did not sufficiently complete a seal and it is unknown if there were audible beeps from the generator, indicating that the seal was complete.The generator used with the vessel sealer instrument and da vinci system is designed to provide a successful confirmation signal to indicate seal completion.However, it is unknown if there was a successful confirmation signal following the reported sealing cycle attempt.Per the description of the complaint, the vessel sealer may have incurred a failure mode that is known to impact sealing effectiveness.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.

• 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: 14250789
• MDR Text Key: 291292915
• Report Number: 2955842-2022-11326
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173337
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: ISIFA2022-01-C
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 90 KG