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

Catalog Number ACE36E

Device Problems Break (1069); Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

It was reported that during a total laparoscopic hysterectomy procedure, the surgeon was using the device and the power went off.After starting the machine, he was activating the probe outside the patient body.During this process the active blade was broken.It is unknown how the procedure was completed.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.Information anticipated, but unavailable at this time.No device received for analysis at time of submission of 3500a.Device evaluation - 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).Should the information be provided later, a supplemental medwatch will be sent.The device was returned with the distal tip of the blade broken off and not returned.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 gen11 an alert screen was displayed.A probable cause of the device stop activating and display an alert 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 alert screens, such as ¿tighten assembly¿, ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure.

• 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: 4077678
• MDR Text Key: 4826075
• Report Number: 3005075853-2014-06287
• 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: 08/29/2014

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: 06/01/2018
• Device Catalogue Number: ACE36E
• Other Device ID Number: BATCH UNK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2014
• Initial Date FDA Received: 09/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE