MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS ACE 14 CM SCISSOR HANDLE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	ACE14S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # 93n6p.Investigation summary: the device was received with the blade broken off and not returned with the device.In addition, the blade was discolored (blue) due to heat generated from contact between the blade and the tissue pad.The blade tip portion may have broken off of the device during transport to our analysis site.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.In addition, photos were also received and analyzed.The images provided by the customer are that of an ace14s device and a gen11 generator.In the images, the blade appears to be discolored and there is an alert screen seen; "replace instrument." a probable cause of blade discoloration is applying pressure between the instrument blade and tissue pad without having tissue between them.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 there were no defects, protocols or ncr(s) found during the manufacturing process related to this complaint.
Event or Problem Description
It was reported that during a tonsillectomy procedure, when the device was assembled, it showed ¿replace instrument¿ when device was activated.There was no patient consequence.

• Brand Name: HS ACE 14 CM SCISSOR HANDLE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7765909
• Report Number: 3005075853-2018-11911
• Device Sequence Number: 13800816
• Product Code: LFL
• UDI-Device Identifier: 20705036000881
• UDI-Public: 20705036000881
• Combination Product (Y/N): N
• PMA/510(K) Number: K051036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2018

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: 01/31/2022
• Device Catalogue Number: ACE14S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/08/2018
• Patient Sequence Number: 1