MAUDE Adverse Event Report: INTEGRA BURLINGTON MA, INC. OJEMAN CORTICAL STIMULATOR

Catalog Number OCS2

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

At the receipt after repair, the device was found to be not working as expected.Stimulation stopped at 38 volts (high voltage is stated to be 40 volts or above).There would not be an insubstantial power being dissipated in the tissue around the probe (i.E.W=vi).There is no indication of a stimulation occurring when there most definitely stimulation occurring.This indication stops working at the higher currents.Product was not in contact with a patient, there was no patient injury or death alleged, and the event did not lead to an increase of surgery time.It was also reported that for use in-house, a current detection system was developed the customer for the osiris cortical stimulator as this had no indication of current at all.If this is used in parallel with the ojemann cortical stimulator then current can be detected even when the ojemann cortical stimulator stops detecting it.

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: OJEMAN CORTICAL STIMULATOR
• Type of Device: NA
• Manufacturer (Section D): INTEGRA BURLINGTON MA, INC.; burlington MA 01803
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr.; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4127868
• MDR Text Key: 20975060
• Report Number: 1222895-2014-00025
• Device Sequence Number: 1
• Product Code: GYC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K924226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OCS2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2014
• 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