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

Catalog Number ACE36E

Device Problems Loss of Power (1475); Defective Device (2588)

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

Event Date 12/10/2014

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the device was defective.The device stopped working.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.The device was returned with tissue pad detached but with evidence of the tissue pad material in the groove section of the clamp arm.The device was connected to a test hand piece and generator and the device did activate during functional testing and no alert screens were displayed.The device was disassembled to inspect the internal components and no anomalies were noted.Based on the condition of the tissue pad, a probable cause for 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.Due to the damage to the tissue pad it is possible a metal to metal contact, resulting on alert screens or activation issues.

• 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: 4484828
• MDR Text Key: 16986946
• Report Number: 3005075853-2015-00863
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K042777
• 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
• Report Date: 12/19/2014

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: 01/24/2019
• Device Catalogue Number: ACE36E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2014
• 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