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

Catalog Number HARH36

Device Problems Melted (1385); Component Missing (2306); Failure to Cut (2587); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.

Event Description

It was reported that during a colectomy procedure, the scissor took more time than usual to cut.No particular mechanical resistance on the trigger.Then, after 10 minutes of use, the plastic attachment melted and got detached.The white plastic of the superior jaws was completely missing.The plastic attachment fell into the patient then was removed and kept.There was no patient consequence.

Manufacturer Narrative

(b)(4).Batch # r94p39.Investigation summary: the analysis results found that the device was received with the tissue pad detached and returned in a plastic bag 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.The device was disassembled to inspect the internal components and no anomalies were found.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.

• 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: 8684832
• MDR Text Key: 148025024
• Report Number: 3005075853-2019-19592
• 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
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: HARH36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Date Manufacturer Received: 05/20/2019
• Patient Sequence Number: 1