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

Catalog Number HARH36

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r94d5h.Investigation summary: 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.In addition, the blade tip was damaged at the distal end due to contact with the clamp arm after the tissue pad was detached away.The device was connected to a test hand-piece and tested on a gen11.The device did activate during functional testing.It is possible that the clamp arm to blade contact could have resulted in an alert screen or activation issues as reported by the customer.This was not confirmed during the analysis.The device was disassembled to inspect the internal components and no anomalies were found.Probable causes of the blade damage are applying pressure between the instrument blade and tissue pad without having tissue between them, subsequent activations would completely wear and melt the tissue pad until the blade tip makes contact with the clamp arm.Avoid activating the blade without tissue between the blade and tissue pad to prevent this type of damage.Based on the condition of the tissue pad, a probable cause of 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.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 laparotomy, segmented liver resection, cholecystectomy, the device passed the pre-test.It had been working and then stopped working.No details were provided on messages displayed by the generator.

• Brand Name: HARMONIC ACE PLUS 7 W ADV HEMOSTASIS
• 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: 8514460
• MDR Text Key: 142240317
• Report Number: 3005075853-2019-18098
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014621
• UDI-Public: 10705036014621
• Combination Product (y/n): N
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2019

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: 08/31/2023
• Device Catalogue Number: HARH36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1