MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 36CM W ERG HANDLE; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	ACE36E
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thyroidectomy the ace36e was not working.The procedure was delayed 10 minutes.It was completed successfully.
Additional Manufacturer Narrative
(b)(4).Batch #: p92906.Additional information was requested and the following was obtained: did the generator display any error messages and if so what were they? tighten assembly / identifying instruments did the device pass the pre-test? yes had the device been working and then stopped? yes did the patient experience any adverse consequences due to this issue?- no investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.The device was received with the blade discolored (blue) due to heat generated from contact between the blade and tissue pad.However, the blade was not cracked.In addition the tissue pad damaged was noted to be melted and 100% present.The device was connected to a test hand piece and a gen11.During functional testing, it was noted that the hand activation buttons were nonfunctional.However, the device did activate when tested with the foot switch.Probable cause of blade discoloration is applying pressure between the instrument blade and tissue pad without having tissue between them.The device was disassembled to inspect the internal components.Corrosion was found at the hand activation domes.Due to the moisture discovered on the instrument, which is evidence of possible reuse, we are unable to determine how this condition impacted the performance of the device and, therefore, cannot conclude root cause.Our manufacturing, sterilization, packaging, and shipment processes do not introduce corrosion / moisture to the device.Once minor blade damage has occurred, subsequent activations may increase the severity of the blade damage.This in turn can result activation issues such as 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.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between them.Avoid activating the blade without tissue between the blade and tissue pad to prevent damage to the tissue pad.Keep the clamp arm open when back cutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.

• Brand Name: HARMONIC ACE 36CM W ERG HANDLE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14142919
• Report Number: 3005075853-2022-02491
• Device Sequence Number: 4293471
• Product Code: LFL
• UDI-Device Identifier: 10705036000938
• UDI-Public: 10705036000938
• Combination Product (Y/N): N
• PMA/510(K) Number: K042777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2022

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: 03/31/2022
• Device Model Number: ACE36E
• Device Catalogue Number: ACE36E
• Device Lot Number: P92906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANDPIECE.
• Patient Sex: Unknown