MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 45CM W ERG HANDLE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	ACE45E
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p93k24.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 during an unknown procedure, the blade tip was broken about 0.3 cm during the procedure.Changed to another one to complete the surgery.The reporter claimed that the whole surgery had been prolonged.No additional information can be provided.

• Brand Name: HARMONIC ACE 45CM W ERG HANDLE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8238319
• Report Number: 3005075853-2019-15711
• Device Sequence Number: 19430431
• Product Code: LFL
• UDI-Device Identifier: 10705036000976
• UDI-Public: 10705036000976
• 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: 08/31/2022
• Device Catalogue Number: ACE45E
• Device Lot Number: P93K24
• 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: 01/10/2019
• Patient Sequence Number: 1
• Patient Age: 64 YR