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 2015-07-08 for OJEMAN CORTICAL STIMULATOR OCS2 manufactured by Integra Burlington, Ma, Inc..
[16454266]
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.
Patient Sequence No: 1, Text Type: D, B5
[16756274]
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.
Patient Sequence No: 1, Text Type: N, H10
[33971413]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2015-00031 |
| MDR Report Key | 4905137 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-07-08 |
| Date of Report | 2015-06-11 |
| Date Mfgr Received | 2015-11-27 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2015-08-03 |
| 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 |
| 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 | 2015-07-08 |
| Returned To Mfg | 2015-07-20 |
| 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 | 2015-07-08 |