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

Model Number 480422-01

Device Problem Failure to Deliver Energy (1211)

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

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

The vessel sealer extend has not been returned for evaluation; therefore, failure analysis of the product related to the complaint has not been performed.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.A review of the site's complaint history does not reveal any related complaints involving this product or this event.No image or procedure video was provided for review.The lot number was not provided.Therefore, an instrument log review of the product related to the complaint cannot be performed at this time.This complaint is being reported based on 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 extend 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 extend may have incurred a failure mode that is known to impact sealing effectiveness with no claim or evidence of mishandling/misuse.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.Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.Insufficient product information was provided in order to obtain the date of manufacture.

Event Description

It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the customer was having problems with the vessel sealer extend instrument.The customer stated that other advanced instruments worked on the e-100 generator, and vessel sealer extend would not work on the erbe generator or the e-100 generator.The customer will be returning the vessel sealer extend due to the lack of sealing effect produced by the instrument.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.

• 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: 13041141
• MDR Text Key: 290149442
• Report Number: 2955842-2021-11778
• 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: 11/22/2021

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: 480422-01
• Device Catalogue Number: 480422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.