MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 23CM W ERG HANDLE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	ACE23E
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p92e9g.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 white tissue pad was fallen off during the procedure.The fallen piece was retrieved by forceps and was disposed.Changed to another one to complete the procedure.There was no report on patient injury.
Additional Manufacturer Narrative
(b)(4).Batch # p92e9g.The analysis results found that the device was received with the tissue pad detached and not returned but with evidence of body fluids and tissue pad material in the groove section of the clamp arm.The device was connected to a test hand piece and a gen11 and the device did activate during functional testing.Based on the condition of the tissue pad, a probable cause for this damage is that the clamp of the device may have been closed and the instrument activated without tissue present.Care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.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.The resulting damage contributes to the removal of the pad from the clamp arm.The cleaning of the pad, not in accordance with the ifu, can also result in removal of the pad during use.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 23CM W ERG HANDLE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7953308
• Report Number: 3005075853-2018-13441
• Device Sequence Number: 941430
• Product Code: LFL
• UDI-Device Identifier: 10705036000891
• UDI-Public: 10705036000891
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2018

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: 04/30/2022
• Device Catalogue Number: ACE23E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 09/22/2018
• Supplement Date Received by Manufacturer: 09/22/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 10/25/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANDPIECE