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	12/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # n92d2c.The batch history records were reviewed and the manufacturing criteria were met prior to the release of this batch.
Event or Problem Description
It was reported that 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 # n92d2c.Investigation summary: the device was received with the hand activations contacts bent and the distal tip of the blade broken off and not returned.The remaining blade portion was scratched, and with evidence of contact with metal in or out of the operative field.Therefore, functional testing could not be performed with the gen11, as the instrument did not engage with the hand piece.The damaged hand activation contacts could cause rotational issues with the device.In addition, it can cause improper torquing of the blade, which could cause the generator to display a communication issue, activation issues, incomplete pre-run test or alert screens.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, 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 activations may increase the severity of the blade damage.This in turn can result in failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result are such as ¿tighten assembly¿, ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damage blade can result in a broken blade.To avoid damaging the contacts, it is recommended to assemble the device vertically.If the hand piece is inadvertently tilted during the assembly with the instrument, the hand activation contacts can be damaged.The batch history record was reviewed and there were no defects, protocols or ncr(s) found during the manufacturing process related to this complaint.

• 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: 7222136
• Report Number: 3005075853-2018-07577
• Device Sequence Number: 11055014
• Product Code: LFL
• UDI-Device Identifier: 20705036000973
• UDI-Public: 20705036000973
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2018

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: 07/31/2021
• Device Catalogue Number: ACE45E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 01/06/2018
• Supplement Date Received by Manufacturer: 01/06/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1