MAUDE Adverse Event Report: INTEGRA LIFESCIENCES IRELAND LIMITED CUSA EXCEL 36KHZ TUBING SET; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C3601

Device Problems Burst Container or Vessel (1074); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2014

Event Type  malfunction  

Event Description

It was reported that when the nurse opened the package, the tubing popped out of the packaging and was "un-sanitized." the customer complained that the packaging of the tubing was not appropriate.The product problem occurred before use.There was no pt injury.Additional info was requested and on (b)(6) 2014, the following was received from the distributor: the pt was not anesthetized when the problem occurred.There was no info provided regarding the pt's age and gender.The type of surgery the product was going to be used for was a hepatectomy.There was a replacement product available to be used.There was no surgery delay and no pt adverse consequence.

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.

• Brand Name: CUSA EXCEL 36KHZ TUBING SET
• Type of Device: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES IRELAND LIMITED; sragh, tullamore; co offaly; sragh tullamore ; EI
• Manufacturer Contact: rowana bunuan ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4098931
• MDR Text Key: 4839276
• Report Number: 3006697299-2014-00093
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C3601
• Device Lot Number: 1135090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1