MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. VESSEL SEALER EXTEND; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Lot Number M91210321

Device Problem Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2021

Event Type  Injury  

Event Description

Vessel sealer extend made strange noise, not working, removed from operating room.Fda safety report id# (b)(4).

• Brand Name: VESSEL SEALER EXTEND
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 12638683
• MDR Text Key: 276858843
• Report Number: MW5104637
• Device Sequence Number: 1
• Product Code: NAY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: M91210321
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR