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

Catalog Number ACE36J

Device Problems Detachment Of Device Component (1104); Failure to Power Up (1476); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2014

Event Type  malfunction  

Event Description

It was reported that during a lap hepatectomy, ¿replace instrument /blade error detected¿ was displayed during use.Although the device was cleaned, the event continued and the device became not to be activated with the hand switch.The tissue pad was detached off when the device was checked on the mayo stand.No pieces fell into the patient.The detached tissue pad was discarded by the hospital.Another device was used to complete the case.There were no adverse consequences to the patient.One device will be returning.

Manufacturer Narrative

(b)(4).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 a small portion not returned.The device was tested with a test handpiece and generator and the device did activate using max and min buttons.No alert screen was displayed.The device was disassembled but no anomalies that could affect the functionality of the hand activation buttons were found.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between them.Avoid activating the blade without tissue between the blade and tissue pad to prevent damage to the tissue pad.

• Brand Name: ULTRACISION HARMONIC ACE
• 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: 4044990
• MDR Text Key: 4907607
• Report Number: 3005075853-2014-06030
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2014

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: 02/12/2019
• Device Catalogue Number: ACE36J
• Device Lot Number: L90L42
• Other Device ID Number: BATCH # NI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 08/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE