MAUDE Adverse Event Report: INTEGRA LIFESCIENCES IRELAND LIMITED CUSA EXCEL 36KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C2602

Device Problems Loss of Power (1475); Self-Activation or Keying (1557); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 12/29/2014

Event Type  Injury  

Event Description

After the operating room nurse assembled the handpiece, it was noted by the distributor that instead of taking 1 minute, the handpiece cooling process was taking longer than usual, approximately 3 minutes.After handpiece cooled, the console made a strange sound and the cooling process restarted again automatically on its own, without any user intervention.On this occasion, the handpiece cooling process took only 1 minute and the amplitude and prime tests were completed satisfactorily.Ten minutes into the procedure, the console lights suddenly turned off and the equipment began recalibrating the handpiece, cooling process and auto-tests.The surgery continued for another 5 minutes until the same event happened again.The distributor performed all the troubleshooting measures, but since the situation persisted, the distributor decided to exchange the handpiece for a different one.Cooling and auto-tests were successful.At some point, when the client pressed the pedal in order to fragment the tissue, the amplitude lights on the console board started flickering and the console simply could not even reach 50% force.The surgeon decided not to use the cusa.Additional information was requested and on 02/12/2015, the following was received from the distributor: patient was a (b)(6) male.When the console lights suddenly turned off and the equipment began recalibrating the handpiece after ten minutes into the procedure, it was in run mode.The handpiece was being used on the patient at the time the event happened again.There was no patient injury reported.There was approximately 1 hour surgical delay.There was no patient adverse consequence as a result of the surgical delay, but anesthesia time was prolonged.There was no product replacement.The surgeon continued the surgery with bipolar, dissector, and suction.Surgery was completed.Patient outcome were reported as "have the expected evolution after the removal of tumor".

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: CUSA EXCEL 36KHZ STRAIGHT HANDPIECE
• Type of Device: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES IRELAND LIMITED; sragh, tullamore, co. offaly ; EI
• Manufacturer Contact: rowena bunaun ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4585009
• MDR Text Key: 5479487
• Report Number: 3006697299-2015-00027
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: PM
• PMA/PMN Number: K141674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C2602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 03/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR