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

Model Number 480275

Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/29/2019

Event Type  malfunction  

Event Description

The intuitive surgical harmonic ace curved shears were not being recognized by the generator.A message to "replace instrument" was displayed.Instrument was replaced with no further issues noted.Fda safety report id# (b)(4).

• Brand Name: HARMONIC ACE CURVED SHEARS ROBOTIC
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 8573416
• MDR Text Key: 143950384
• Report Number: MW5086320
• 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: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: 480275
• Device Catalogue Number: 480275
• Device Lot Number: M10190120
• Was Device Available for Evaluation?: Yes
• 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 Age: 55 YR