MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE PLUS 7 ADV HEMOSTASIS 45; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARH45

Device Problems Failure to Cut (2587); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r94859.Investigation summary: the device was returned with the tissue pad damaged, melted and 100% present.The device was connected to a test hand piece and tested on a gen11.The device was functional when the max or min hand activation buttons were pressed.There were no anomalies noted with the functionality of the device.The instrument was disassembled to inspect the internal components, no evidence was found that could have caused the reported activation issues.It is possible that the issue encountered was due to the hand piece contacts being dirty.It is recommended that the surface of the hand piece gold ha contacts be cleaned periodically or when dirty.Failure to do so can result in no hand activation function.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between them.Prolonged usage of advanced hemostasis mode may cause tissue pad damage.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, after the harh45 coded device sealed, it didn't switched to 2nd sound tone and it didn't cut the tissue.Energy button was held on a long time and that resulted with the tissue holding pad dividing into two pieces.No patient consequence reported.

• Brand Name: HARMONIC ACE PLUS 7 ADV HEMOSTASIS 45
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 9039598
• MDR Text Key: 202780343
• Report Number: 3005075853-2019-21949
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014638
• UDI-Public: 10705036014638
• Combination Product (y/n): N
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: HARH45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1