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

Catalog Number HARH36

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 04/17/2015

Event Type  malfunction  

Event Description

It was reported that during an mis salpingo oophorectomy procedure, the patient had a large cyst by the ovary.Mobilization of the ovary was very challenging as there were adhesions.When taking a large bundle, the surgeon burnt the vessels with a bipolar.They then activated the device in advanced hemostatis mode.When the att kicked in, the surgeon released the advanced hemostasis button and activated it again.This took time as there was still tissue in the distal tip.After this was complete when the tissue fell off, the white plastic clamp fell off.The surgeon removed the product and opened a new device to complete the procedure.There was no adverse consequence to the patient.

Manufacturer Narrative

(b)(4).Information is unavailable; device not returned.No device received for analysis at time of submission of 3500a.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.

Manufacturer Narrative

(b)(4).Additional information: the device was returned with the tissue pad damaged, melted and 100% present and not detached as reported by the customer.The device was connected to a test hand piece and gen11 and it did activate during functional testing.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between the jaws.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.

• 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: 4727714
• MDR Text Key: 5746199
• Report Number: 3005075853-2015-02615
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2015

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: 01/20/2020
• Device Catalogue Number: HARH36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 04/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2015
• 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