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

Model Number 480422-01

Device Problems Failure to Deliver Energy (1211); Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the vessel sealer extend involved with this complaint and completed the device evaluation.Failure analysis did not confirm the reported event.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests and moved intuitively with full range of motion in all directions.The jaw grip verification passed and the grips opened / closed properly.Visual inspection revealed the blade was not exposed outside of the blade garage and ceramic dots were present on the jaw.Energy was delivered without any issues and passed the cut test.Review of the system logs did not reveal any related errors.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.Per the instruction for use (ifu), before removing instruments during a procedure, confirm that the surgeon is ready, has the instrument in full view, and has straightened the instrument wrist and closed the jaws.In addition, always have a backup instrument available to complete the surgical procedure in case of instrument failure.This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, the vessel sealer instrument did not seal.While there was no patient harm, adverse outcome or injury reported, recurrence of the reported malfunction could cause or contribute to an adverse event.It is unknown what caused the sealing issue.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the vessel sealer extend did not seal.The surgeon used a back up instrument to complete the procedure without injury.Additional information has been requested regarding the circumstances of event, however, no response has been received.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 9454126
• MDR Text Key: 193595985
• Report Number: 2955842-2019-10956
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(17)210930(10)L90190911
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Lot Number: L90190911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1