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

Catalog Number C2602

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

Too much water was reported.Add'l info was requested and on (b)(6) 2015, the following was provided the product was just received back from repair and it leaked, requiring a second tray to be opened.No harm was done to the pt.No other info was provided.

Manufacturer Narrative

To date, 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: evaluation of actual device review of device history records review of complaints history conclusion: the customer complaint incident ¿too much water¿ was verified and duplicated.Customer complaint was confirmed.Dhr review was completed for cusa excel handpiece serial number (b)(4)work order (b)(4), manufactured in valley lab, usa to identify any recorded anomalies that could be associated to the complaint incident.Date of manufacture: (b)(6) 2005.No non-conformance reports were raised during the manufacturing process for this handpiece.The dhr review has been deemed satisfactory.A minimum of 12 months review was completed in trackwise® using the following key words ¿alignment issue¿ and a root cause ¿tubing or cord failure¿ in the search criteria.The key word search review contained all and/or part of the key words to complete a comprehensive trend review; 9 complaints contained the search criteria.Conclusion: the failure analysis investigation has concluded the cause of the handpiece leakage was due to the worn cooling tube cable which had a small hole at the coil form.

• 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 (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: 4859158
• MDR Text Key: 5809274
• Report Number: 3006697299-2015-00085
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K141674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2005
• 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