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 Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the device was not producing enough.There was no patient contact, no patient prepped for surgery, no patient injury, and no delay in surgery.

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.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(4) 2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: the complaint incident was duplicated.The ocs2 dhr was requested from the manufacturing facility integra billerica appendix 1.The dhr was reviewed for ocs2 ojeman cortical stimulator serial number 1131.Date of manufacture: 2008 ¿dec.No non-conformance reports were raised during the manufacturing process for this monitor.The dhr review verified all the functionality tests were carried out accordingly and all results of the tests were recorded as within specification prior to the ocs2 been released.Rate of occurrence: during the time period ¿jun 2014 to nov 2015, the quantity of complaints (b)(4) over the review period with the key word identified in the complaint review can therefore be calculated as (b)(4).Conclusion: the root cause of the complaint incident was verified as loose battery clips causing an intermittent power supply to the ocs2 monitor.

• Brand Name: OJEMAN CORTICAL STIMULATOR
• Type of Device: NA
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC.; burlington MA 01803
• Manufacturer (Section G): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; burlington MA 01803
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4905137
• MDR Text Key: 16454266
• Report Number: 1222895-2015-00031
• Device Sequence Number: 1
• Product Code: GYC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Date Manufacturer Received: 11/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2008
• 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