MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARH36

Device Problems Failure to Cut (2587); Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

Event Description

It was reported that the scalpel hard to cut, and the white tissue pad was detached and rolled during procedure.Changed to another one to complete surgery.There was no patient consequence reported.

Manufacturer Narrative

(b)(4).Batch # t92633.Investigation summary: the device was returned with the tissue pad shifted to proximal side.In addition, the tissue pad was attached to the clamp arm and not detached as reported by the customer.The device was connected to a test handpiece and a gen11, and the device did activate during functional testing.Due to the condition of the device, we were unable to investigate further the tissue effect issues reported.This is not a common occurrence.It is possible that the pad tip made contact with something that could have shifted it.No other anomalies were noted.No conclusion could be made as to how the tissue pad shifted from the clamp arm.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8786373
• MDR Text Key: 151015554
• Report Number: 3005075853-2019-20373
• 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
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

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: 12/31/2023
• Device Catalogue Number: HARH36
• Device Lot Number: T92633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 08/07/2019
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE.