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); Contamination of Device Ingredient or Reagent (2901); Device Packaging Compromised (2916)

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

Event Type  malfunction  

Event Description

This is the third of three reports (same product id, same lot number, same problem, different occasions).Linked to manufacturing report numbers: 3006697299-2014-00116 and 3006697299-2014-00114.When the package was opened by the operating room staff inside the operating room, the part pops out.This results in the entire tubing set being unsterile and therefore unusable.The device was not in contact with a patient and there was no patient injury.The event did not lead to an increase in surgery time.Additional information received on (b)(6) 2014: it was clarified that there were 3 devices with packaging issues that occurred on three different occasions.The exact date of events were unknown.All three events happened during week 39 ((b)(6) 2014).There was no consequence for the patient.Patient age and gender, if the patient was under anesthesia when the issue occurred, and type of surgery were all unknown.The medical staff had to open a new package with another lot in order to finish/continue the procedure.It was reported that the problem was that the part pops when opening the package and the risk of unsterility.

Manufacturer Narrative

The device involved in the reported incident is not expected to be received for evaluation.The product was discarded by the customer.An investigation has been initiated based upon the reported information.

• Brand Name: CUSA EXCEL 36KHZ TUBING SET
• 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: 4216818
• MDR Text Key: 4995114
• Report Number: 3006697299-2014-00115
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• 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: 0000001141953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2014
• 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