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

Catalog Number ACE36E

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

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

Event Date 05/30/2014

Event Type  malfunction  

Event Description

It was reported that prior to an unknown procedure the generator displayed instrument assembly error.While cleaning with wet gauze, the jaw of the probe got broken by the nurse.One device will be returning.

Manufacturer Narrative

(b)(4).The device was returned with the distal tip of the blade broken off and returned with the device.The remaining blade portion was scratched ¿ evidence of contact with metal in or out of the operative field.The device was functionally tested with a generator.During functional testing on the gen11 generator, the ¿instrument error¿ alert was displayed.A probable cause of the device to stop activating and display an instrument error screen is blade damage.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, staples or clips during the procedure or using any means other than the blade wrench to attach or detach the blade.Once minor blade damage has occurred, subsequent activations may increase damage severity and result in yellow alert screens, such as ¿tighten assembly¿ or ¿blade error detected¿ followed by a ¿replace instrument¿ screen later in the procedure, and continued usage can result in a broken blade.

Manufacturer Narrative

(b)(4).Information anticipated, but unavailable at this time.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.

• 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: 3855671
• MDR Text Key: 4659521
• Report Number: 3005075853-2014-03837
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 06/02/2014

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: 04/20/2018
• Device Catalogue Number: ACE36E
• Other Device ID Number: BATCH # K91570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 06/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE