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

Model Number HARH45

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2021

Event Type  malfunction  

Event Description

Harmonic ace scalpel did not function properly and is not working.

• 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: 11453106
• MDR Text Key: 238874835
• Report Number: 11453106
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HARH45
• Device Catalogue Number: HARH45
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1