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

Catalog Number C2602

Device Problems Loss of Power (1475); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Event Description

It was reported that on an unk date, the handpiece failed during surgery.No other information was provided.Preliminary evaluations by an integra lifesciences senior field service representative at the user facility on (b)(6) 2014 found the handpiece had 0 watts power with the transducer twisted.It appeared that the tip was attempted to be removed without the torque base.Customer was advised to have the handpiece returned to integra for further evaluation/repair.Additional information has been requested.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: CUSA EXCEL 36KHZ STRAIGHT HANEPIECE
• Type of Device: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LIMITED; sragh, tullamore, co. offaly ; EI
• Manufacturer Contact: rowena bunuan ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4152346
• MDR Text Key: 15910603
• Report Number: 3006697299-2014-00105
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CUSA CONSOLE SERIAL NUMBER: (B)(4)