MAUDE Adverse Event Report: INTEGRA LIFESCIENCES IRELAND LIMITED CUSA EXCEL 23KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C2600

Device Problems Crack (1135); Device Displays Incorrect Message (2591); Failure to Shut Off (2939); Material Twisted/Bent (2981)

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

Event Date 11/19/2014

Event Type  malfunction  

Event Description

The hosp contacted integra lifesciences (ils) service ctr during the procedure to see if they could get service tech assistance as the "cusa stopped".The hosp has one 23khz handpiece only so the liver resection had to continue with clips and diathermy.Integra service tech went to the hosp the same day and found that the handpiece was cracked and that the transducer was twisted.It was advised to have the handpiece returned to ils service ctr in melbourne for repair.The cusa console had no issues.Additional info was requested and on (b)(6) 2014, the following was obtained form the biomed engineer at the hosp: the 60 year old male patient with an underlying medical condition of metastatic colon cancer was to underwent a non anatomical liver resection x 5 on (b)(6) 2014.It was clarified that the cusa did not stop mid procedure but the issue was detected during setup.The cusa was never used as the alarm detected a fault on the console when priming the handpiece.The alarm was the handpiece alarm.The patient was already anesthetized and in the operating room (or) suite when the product problem occurred.The user facility engineer couldn't remember exactly how long the surgical delay was but it was between 30 to 60 minutes.The delay was estimated based on how long it then took them to organize the different set up for the patient.Altered surgical technique included use of crushing clamp, diathermy, and ligaclips to obtain hemostasis.Patient outcome was reported as "uneventful surgery other than the cusa breakdown, patient discharged day 5".

Manufacturer Narrative

Integra service tech went to the hosp the same day of the surgery and found that the handpiece was cracked and the transducer twister.It was advised to have the handpiece returned to ils service ctr in melbourne for repair.To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported info.

• Brand Name: CUSA EXCEL 23KHZ STRAIGHT HANDPIECE
• Type of Device: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES IRELAND LIMITED; sragh tullamore, co offaly ; EI
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4350877
• MDR Text Key: 5144370
• Report Number: 3006697299-2014-00139
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K981262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C2600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 60 YR