OJEMAN CORTICAL STIMULATOR OCS2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-03-10 for OJEMAN CORTICAL STIMULATOR OCS2 manufactured by Integra Burlington Ma, Inc.

Event Text Entries

[5463542] When the volume knob was fully on, there was no output from the unit. There was no patient contact, no patient injury, no delay in surgery. Additional info has been requested.
Patient Sequence No: 1, Text Type: D, B5


[13010805] 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.
Patient Sequence No: 1, Text Type: N, H10


[36737369] Integra has completed their internal investigation on 12/17/2015. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaints history. Results: 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 ojemann monitor serial number (b)(4). Date of manufacture: 2008? Dec. No non-conformance report was 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 monitor been released. (b)(4). Conclusion: 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1222895-2015-00009
MDR Report Key4594713
Report Source06,USER FACILITY
Date Received2015-03-10
Date of Report2015-02-13
Date Mfgr Received2015-12-17
Device Manufacturer Date2008-12-01
Date Added to Maude2015-04-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. ROWENA BUNUAN
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA BURLINGTON, MA, INC.
Manufacturer Street22 TERRY AVENUE
Manufacturer CityBURLINGTON MA 01803
Manufacturer CountryUS
Manufacturer Postal Code01803
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOJEMAN CORTICAL STIMULATOR
Generic NameNA
Product CodeGYC
Date Received2015-03-10
Returned To Mfg2015-02-27
Catalog NumberOCS2
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA BURLINGTON MA, INC
Manufacturer AddressBURLINGTON MA 01803 US 01803


Patients

Patient NumberTreatmentOutcomeDate
10 2015-03-10

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