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

Model Number HARH36

Device Problem Failure to Cut (2587)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2023

Event Type  malfunction  

Event Description

The harmonic handpiece that was being used during the procedure stopped working properly, it would not cut through the tissue.The defective handpiece was removed from the field and a new handpiece was opened.

• Brand Name: HARMONIC ACE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 16673456
• MDR Text Key: 312630991
• Report Number: 16673456
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARH36
• Device Catalogue Number: HARH36
• Device Lot Number: W7019P
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17885 DA
• Patient Sex: Female
• Patient Weight: 62 KG