MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LIMITED CUSA NXT SYSTEM 24KHZ; SELECTOR-NXT CONVENIENCE KITS

Catalog Number NN1H24

Device Problems Continuous Firing (1123); Device Remains Activated (1525)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

This is the first of two reports (same user facility, same product id, different serial numbers).An out of box failure was reported.There was no pt contact, no pt injury, no delay in surgery, no pt prepped for surgery.Add'l info was requested and on 01/08/2015, the following info was received from the integra sales rep: the unit said the foot pedal was broken.When the foot pedal was switched, it still said it was broken.The sales rep reset the unit several times and got the unit to work.After that, every time he turned the unit on, it would say the foot pedal was broken until he unplugged the foot pedal and plugged it back in, sometimes several times, then it would work again.

Manufacturer Narrative

The device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: the customer complaint incident was verified and duplicated.The dhr review was completed for cusa nxt console serial number (b)(4) and service module (b)(4), date of manufacture: (b)(6) 2014 ¿ (b)(6) 2014.The dhr reviews confirmed all the functionality tests were carried out accordingly and all results of the tests were recorded as within specification prior to the cusa nxt console and service module been released.Rate of occurrence: during the time period (b)(6) 2013 to (b)(6) 2015, the quantity of complaints over the review period with the key words identified in the complaint review can therefore be calculated as (b)(4) of procedures.Conclusion: the root cause of the footswitch connection issue was identified a damaged pin on the console¿s footswitch connector.

• Brand Name: CUSA NXT SYSTEM 24KHZ
• Type of Device: SELECTOR-NXT CONVENIENCE KITS
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LIMITED; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4491373
• MDR Text Key: 15315619
• Report Number: 3006697299-2015-00008
• Device Sequence Number: 1
• Product Code: GWM
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: NN1H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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