MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES, LTD. SELECTOR 24KHZ NEURO SHORT HANDPIECE

Catalog Number 1523000M7

Device Problem Fluid/Blood Leak (1250)

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 serial number, same product problem, different pts, different incidents).The hand piece keeps leaking irrigation water profusely out of the back where the tubing is connected.This has happened three times that the customer has told the sales representative about.Each time, the sales representative has gone to the account after the case was completed, set up the tubing and handpiece, and ran a series of tests for long periods of time to replicate the issue.The sales representative has never been able to see the reported leak.Additional info 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: SELECTOR 24KHZ NEURO SHORT HANDPIECE
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD.; andover hampshire SP10 4DR; UK SP104DR
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr.; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4088806
• MDR Text Key: 19591103
• Report Number: 8010219-2014-00041
• Device Sequence Number: 1
• Product Code: LFL
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2014

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: 1523000M7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2014
• Initial Date FDA Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1