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

Catalog Number C2602

Device Problems Break (1069); Fluid/Blood Leak (1250); Material Twisted/Bent (2981); Output below Specifications (3004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2014

Event Type  malfunction  

Event Description

It was reported that one handpiece caused the cusa power problem with both cusa consoles.There was no patient injury.There was a one hour surgical delay reported.On (b)(6) 2014, an integra service engineer went to the user facility to evaluate the cusa consoles.Both consoles were evaluated and found to be operating within factory specifications.However, the handpiece was found to only have 50-70% ultrasonic power and the transducer was twisted, handpiece broken.It was recommended to the user facility to send the handpiece to integra service ctr to be repaired.Additional info was requested and on (b)(6) 2014, the following was provided by the customer: the cusa power problem occurred during a neurosurgery on (b)(6) 2014, right when the cusa was set from the start, it did not work.The tubing and tip were also changed but the result was still insufficient to the surgeons.The customer received a call from the or to attempt to troubleshoot the problem.One of their experienced scrub techs assembled the handpiece.The surgeon complained that the handpiece was not cutting properly.The product was used on the patient (age and gender were not provided).There was no patient injury.When the customer walked into the or suite to assist on the problem, a second generator and handpiece was already set up and being used.However, it was noticed that the second handpiece was dripping water on the second unit (clarification/request for additional info sent).It was later believed that the irrigation tubing may have been pinched during set up.The one hour surgical delay was due to the attempt to troubleshoot and locate a spare machine and handpiece.There was no patient harm because of the surgical delay.It was reported that at that point, a loaner unit from another facility was received and that worked just fine.

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 info.

• 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 bunuan ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4320645
• MDR Text Key: 19721828
• Report Number: 3006697299-2014-00118
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2014

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 Catalogue Number: C2602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2014
• Initial Date FDA Received: 11/07/2014
• 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
• Treatment: TWO CUSAEXCEL2 CONSOLES,