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

Model Number HAR9F

Device Problems Display or Visual Feedback Problem (1184); Defective Component (2292); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2021

Event Type  malfunction  

Event Description

When the harmonic focus 9cm ultrasonic shears was used, the screen of the harmonic focus kept going back to the page that says "activate instrument for 2 seconds to run test".The harmonic focus handpiece was then unplugged from the 1st harmonic machine, and then plugged into a 2nd harmonic machine.Then, the 2nd harmonic machine says "replace handpiece." the harmonic cord's life shows "88" lives left.

• Brand Name: HARMONIC FOCUS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 11946111
• MDR Text Key: 254500642
• Report Number: 11946111
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HAR9F
• Device Catalogue Number: HAR9F
• Device Lot Number: 12089877
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2021
• Date Report to Manufacturer: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10950 DA