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

Catalog Number ACE36E

Device Problems Burst Container or Vessel (1074); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information is unavailable; device not returned.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.Batch #unk.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot/batch.Additional information requested: for clarification, the event says ¿the device presented an error¿, did the generator display a message and if yes, what was the message? for clarification, the event says ¿the tip of the device burst¿, did the titanium tip break off of the device? did the white teflon pad fall off of the device? did the detached part fall into the patient? was the detached part retrieved from the patient? is the detached part being returned with the device? or, was the detached part discarded? please, explain the meaning of the ¿the tip of the device burst.'¿ is this device being returned for evaluation?.

Event Description

It was reported that before a rectosigmoidectomy procedure, in the beginning of the surgery the device presented an error.It was made an attempt of a new test but the tip of the device burst.Another like device was used to complete the procedure.There were no adverse consequences for the patient.Unknown is the device will be returned.

Manufacturer Narrative

(b)(4): batch #m90647.The device was returned with the distal tip of the blade broken off and it was returned with the device.The remaining blade portion was scratched, and with 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.The batch history records were reviewed with no anomalies noted during the manufacturing process.

• 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: 5382830
• MDR Text Key: 36741221
• Report Number: 3005075853-2016-00454
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2020
• Device Catalogue Number: ACE36E
• Device Lot Number: M90647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2015
• 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