MAUDE Adverse Event Report: INTUITIVE SURGICAL INC HARMONIC ACE CURVED SHEARS; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 480275

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 10/21/2019

Event Type  malfunction  

Event Description

Intuitive surgical davinci xi harmonic ace curved shears stopped coagulating tissue in the middle of the surgical procedure.Fda safety report id# (b)(4).

• Brand Name: HARMONIC ACE CURVED SHEARS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC; sunnyvale CA 94086
• MDR Report Key: 9472922
• MDR Text Key: 171552739
• Report Number: MW5091672
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 480275
• Device Catalogue Number: 480275
• Device Lot Number: M10190312
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2019
• 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 Age: 61 YR