MAUDE Adverse Event Report: INTEGRA BURLINGTON MA, INC OJEMAN CORTICAL STIMILATOR; NONE

Catalog Number OCS2

Device Problems No Audible Prompt/Feedback (2282); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

It was reported that the probe did not make any sound while in use.Multiple probes were tried.Add'l 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 info.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2015.The investigation included: evaluation of actual device review complaint history review of complaints history the complaint incident could not be duplicated or confirmed.The ocs2 ojemann monitor was verified as performing to specification.The dhr was reviewed for ocs2 ojeman cortical stimulator serial number (b)(4).Date of manufacture: (b)(6) 2008.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 ¿(b)(6)2015¿, the global product usage for ocs2 ojeman cortical stimulator was calculated as 4,427 usages, using the total quantity of ocs stimulator probes to calculate the quantity of usages.The quantity of complaints (1) over the review period with the key word identified in the complaint review can therefore be calculated as 0.02 % (1/4427).Since the complaint incident could not be duplicated and the ocs2 monitor was verified as performing to specification, no root cause can be established for the complaint incident.

• Brand Name: OJEMAN CORTICAL STIMILATOR
• Type of Device: NONE
• 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: 4824491
• MDR Text Key: 5839619
• Report Number: 1222895-2015-00025
• 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: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• 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: 05/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2008
• 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