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

Model Number HARH45

Device Problems Failure to Cut (2587); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

The device was not able to cut and coagulate.

• 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: 16067378
• MDR Text Key: 306333628
• Report Number: 16067378
• 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: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HARH45
• Device Catalogue Number: HARH45
• Device Lot Number: P30289P01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2022
• Date Report to Manufacturer: 12/29/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA