MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CUSA; INSTRUMENT, ULTRASONIC SURGICAL

Model Number CUSA NXT

Device Problem Fluid/Blood Leak (1250)

Patient Problem Burn, Thermal (2530)

Event Date 06/17/2014

Event Type  malfunction  

Event Description

During orbital decompression and bone removal the cusa was being used to remove bone tissue.The hand piece has an irrigation and suction sleeve and a tip is inserted which vibrates longitudinally to break up bone or tissue.During use, the tip was getting plenty of irrigation designed to keep it cool, but a lot of irrigation was also coming out of the back of the handpiece, which should not happen.The first hand piece was removed and a second hand piece connected but fluid still leaked out of the back of the hand piece.Two small thermal burns were noted on the right lateral canthus, measuring 5x3mm and 4x2mm.When this was identified, the physician stopped using the device.The device was in use for less than 2 minutes.The thermal burns were minor and repaired at that time.The patient left the or in stable condition.At this time unknown whether further repair of thermal injury will be needed.
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manufacturer response for cusa hand held device, cusa (per site reporter).
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manufacturer wishes to examine device.

• Brand Name: CUSA
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 3908436
• MDR Text Key: 4667032
• Report Number: 3908436
• Device Sequence Number: 1
• Product Code: LFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CUSA NXT
• Device Catalogue Number: CUSA NXT
• Device Lot Number: NAJ13021021E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2014
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR