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.
[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
| Report Number | 1222895-2015-00009 |
| MDR Report Key | 4594713 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-03-10 |
| Date of Report | 2015-02-13 |
| Date Mfgr Received | 2015-12-17 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2015-04-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ROWENA BUNUAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA BURLINGTON, MA, INC. |
| Manufacturer Street | 22 TERRY AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OJEMAN CORTICAL STIMULATOR |
| Generic Name | NA |
| Product Code | GYC |
| Date Received | 2015-03-10 |
| Returned To Mfg | 2015-02-27 |
| Catalog Number | OCS2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA BURLINGTON MA, INC |
| Manufacturer Address | BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-10 |