MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LIMITED CUSA NXT CONSOLE (115-230V); ULTRASONIC SURGICAL PRODUCTS

Catalog Number CUSANXT

Device Problems Fluid/Blood Leak (1250); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 06/17/2014

Event Type  Injury  

Event Description

This is the fourth of four reports (same pt, same incident, different product ids/serial numbers).This report is in regards to the cusa nxt console.Linked to mfg report number: 8010219-2014-00033 (1523000m7p; 24k neuro probe short with serial number: (b)(4)), mfg report number: 8010219-2014-00034 (1523000m7p; 24k neuro probe short serial number: (b)(4)) and mfg report number: 8010219-2014-00032 (1517079 selector sterile tubing kit).(b)(4) was received on (b)(4) 2014 with the following infp: age at time of event: (b)(6) female; date of event: (b)(6) 2014; date of this report: (b)(4) 2014.Original intended procedure: orbital decompression and bone removal.Product returned to mfr on (b)(4) 2014.During orbital decompression and bone removal, the cusa was being used to remove bone tissue.The handpiece 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 handpiece was removed and a second handpiece connected but fluid still leaked out of the back of the handpiece.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 pt left the operating room in stable condition.At this time unk whether further repair of thermal injury will be needed.

Manufacturer Narrative

To date, the device involved in the reported incident has been received for eval.An investigation has been initiated based upon the reported info.

• Brand Name: CUSA NXT CONSOLE (115-230V)
• 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: 4001411
• MDR Text Key: 4779645
• Report Number: 3006697299-2014-00066
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2014

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: CUSANXT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention
• Patient Age: 44 YR