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

Catalog Number ACE36J

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.Batch #m91f20.The device was received with the blade broken off and not returned with the device; in addition the blade was discolored (blue) due to heat generated from contact between the blade and the tissue pad.This blade tip portion may have broken off of the device during transport to our analysis site.The reported complaint was for an activation issue.The device was functionally tested with a gen04.During functional testing an error code 5 was displayed.A probable cause of the device not activating and displaying an error code 5 is blade damage.Probable cause of blade discoloration is applying pressure between the instrument blade and tissue pad without having tissue between them.Once minor blade damage has occurred, subsequent activations may increase damage severity and result in an error code 5.The batch history records were reviewed with no anomalies noted during the manufacturing process.

Event Description

It was reported that during an unknown procedure, the device became not to be activated in the middle of the operation.The blade tip was not broken off and no pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.

• Brand Name: ULTRACISION HARMONIC ACE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5230623
• MDR Text Key: 31612688
• Report Number: 3005075853-2015-07444
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2015

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: 04/22/2020
• Device Catalogue Number: ACE36J
• Device Lot Number: M91F20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2015
• 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