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

Model Number 480422-01

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

Intuitive has received the vessel sealer extend instrument associated with this complaint and completed investigations.Failure analysis investigations did not replicated nor confirm the customer reported complaint.The vessel sealer extend instrument was placed and driven on an in-house system and it passed the recognition and engagement tests.The vessel sealer extend instrument moved intuitively with full range of motion in all directions.The grip opened and closed properly.The instrument was fully functional.The vessel sealer extend instrument passed the energy delivery, ceramic dots, and the cut test.Jaws moved properly.It was also confirmed that no fragments were found to be missing.This complaint is being reported due to the following conclusion: it was reported that during a da vinci-assisted surgical procedure, the jaws of the vessel sealer instrument locked in place, fragment fell inside the patient and unknown if the fragment was retrieved.However, based on an evaluation of the vessel sealer extend instrument, there is no indication that a malfunction of the instrument occurred.The site has reported an injury, and at this time there is no additional information regarding the reported injury.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the jaws of the vessel sealer instrument locked in place, fragment fell inside the patient and unknown if the fragment was retrieved.The site has reported an injury.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 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: 9015551
• MDR Text Key: 161812663
• Report Number: 2955842-2019-10706
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(17)210531(10)M91190505
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Lot Number: M91190505 0189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other