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

Model Number REF: 410322

Device Problem Activation Failure (3270)

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

Event Date 12/14/2020

Event Type  Injury  

Event Description

Vessel sealer not activating; connections and cords checked per guidance of intuitive surg mfr rep replaced with new instrument with no further issues.Ref: (b)(4), lot: m90200310, exp: 2022-03-31.Fda safety report id# (b)(4).

• Brand Name: VESSEL SEALER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 11076461
• MDR Text Key: 224100798
• Report Number: MW5098539
• Device Sequence Number: 1
• Product Code: NAY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: REF: 410322
• Device Lot Number: M90200310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention