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

Catalog Number HARH45

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: p91u6l.Investigation summary: the device was returned with the tissue pad damaged, melted, not all present, and a small portion was not returned.In addition, the tissue pad was attached to the clamp arm and not detached as reported by the customer.Then the device was connected to a test handpiece and a gen11 and the device did activate during functional testing.The tissue pad damage could have tissue effects when used in this condition, affecting the device cutting and sealing performance.When the device was disassembled to inspect the internal components, no anomalies were found.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 a laparoscopy, the customer stated that white piece on the tip of the device had separated from the metal piece.The pad was detached completely during surgery and not clear whether the pad fell off inside the patient, or outside in the sterile field, however, the pad was retrieved.There was no indication that any harm was done, or that the procedure was lengthened to retrieve any pieces.Customer also noted that the device did not cut properly on one side of the tip.Fragments were generated but were removed easily without additional intervention.A second like device was used to complete the procedure.There were no patient consequences 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: 8941716
• MDR Text Key: 199540138
• Report Number: 3005075853-2019-21592
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014638
• UDI-Public: 10705036014638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: HARH45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1