MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC HARMONIC FOCUS; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HAR9F

Device Problems Device Alarm System (1012); Output Problem (3005)

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

Event Date 01/09/2023

Event Type  malfunction  

Event Description

Harmonic focus gave error upon initial usage.Error read "relax pressure on the blade" while it was not in use and the blade was open.Replaced with another harmonic focus which worked without switching reusable cord.

• Brand Name: HARMONIC FOCUS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC
• MDR Report Key: 16233850
• MDR Text Key: 308081403
• Report Number: MW5114456
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HAR9F
• Device Lot Number: 968A02
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female