MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 23CM W ERG HANDLE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	ACE23E
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # l9357u.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot/batch.
Event or Problem Description
It was reported that the titanium tip was broke during the procedure.Changed to another one to complete surgery.There was no report on the patient injury.

• Brand Name: HARMONIC ACE 23CM W ERG HANDLE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8242371
• Report Number: 3005075853-2019-15854
• Device Sequence Number: 11260396
• Product Code: LFL
• UDI-Device Identifier: 10705036000891
• UDI-Public: 10705036000891
• Combination Product (Y/N): N
• PMA/510(K) Number: K042777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: ACE23E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/11/2019
• Patient Sequence Number: 1