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	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that during an unknown procedure, the titanium tip broke during the procedure.The broken piece was retrieved by forceps and was discarded.Changed to another one to complete the procedure.There was no report on patient injury.
Additional Manufacturer Narrative
(b)(4).Batch # p93f7k.Investigation summary: the device was returned with the distal tip of the blade broken off and not returned.The remaining blade portion was scratched and had evidence of contact with metal in or out of the operative field.During functional testing on a gen11, an alert screen was displayed.A probable cause for the device to stop activating and for the gen11 to display an alert screen is blade damage probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, contact with staples or clips during the procedure or using any means other than the blade wrench to attach or detach the blade.Once minor blade damage has occurred, subsequent activation may increase the severity of the blade damage.This, in turn, can result in the device failing the pre-run test with the generator and displaying an alert screen.The alert screens that can result may include ¿tighten assembly,¿ ¿blade error detected,¿ or "relax pressure on blade," followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damaged blade can result in a broken blade.The batch history record was reviewed and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

• 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: 7653036
• Report Number: 3005075853-2018-11062
• Device Sequence Number: 11039950
• Product Code: LFL
• UDI-Device Identifier: 20705036000973
• UDI-Public: 20705036000973
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 07/27/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANDPIECE