MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE + 7; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARH36

Device Problems Melted (1385); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

It was reported that during a total laparoscopic hysterectomy procedure, the doctor activated the device in advanced hemostasis mode well past the secondary tone.He continued to activate into "abuse mode" and melted the inactive pad.There were no patient consequences.Case completed with another device of the same product code.

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.The device was returned with tissue pad detached and returned, but with evidence that the tissue pad was present for some of the case.The device was tested with a generator and all buttons were functional.There were no anomalies or alert screens noted with the functionality of the device 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 backcutting 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.Cleaning of the pad, not in accordance with the ifu, can also result in removal of the pad during use.

• Brand Name: HARMONIC ACE + 7
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4731125
• MDR Text Key: 18259914
• Report Number: 3005075853-2015-02643
• Device Sequence Number: 1
• Product Code: LFL
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2015

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: 11/01/2019
• Device Catalogue Number: HARH36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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
• Treatment: GENERATOR AND HANDPIECE