MAUDE Adverse Event Report: INTUITIVE SURGICAL OPERATIONS VESSEL SEALER; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Lot Number M91210607

Device Problem Noise, Audible (3273)

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

Event Date 09/27/2021

Event Type  malfunction  

Event Description

The vessel sealer worked correctly at the beginning of use and then despite the generator lighting up and the "sealing" noise being made the instrument was not doing anything to the tissue.No harm was caused and the instrument was replaced.Fda safety report id# (b)(4).

• Brand Name: VESSEL SEALER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL OPERATIONS; sunnyvale CA 94086
• MDR Report Key: 12952791
• MDR Text Key: 281927920
• Report Number: MW5105840
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2021

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 Expiration Date: 06/30/2023
• Device Lot Number: M91210607
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male