MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-26 for OJEMAN CORTICAL STIMULATOR OCS2 manufactured by Integra Burlington, Ma, Inc..
[29941074]
It was reported that the output was low. There was no patient contact, injury or delay in surgery. There was no patient prepped for surgery. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[33971421]
Integra has completed their internal investigation on (b)(6) 2015. The investigation included: the ocs2 monitor was not returned to integra for failure analysis investigation. The customer complaint review did not identify an adverse trend. No further review was deemed necessary, future incidents of this nature will be monitored and documented for recurrence and trending purposes. The ocs2 dhr was requested from the manufacturing facility integra billerica appendix 1. 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 3,654 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. 027% (1/3654). Root cause could not be determined since the product was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2015-00037 |
| MDR Report Key | 5178726 |
| Date Received | 2015-10-26 |
| Date of Report | 2015-09-29 |
| Date Mfgr Received | 2015-12-01 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2015-10-26 |
| 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 | N/A |
| Product Code | GYC |
| Date Received | 2015-10-26 |
| Catalog Number | OCS2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA BURLINGTON, MA, INC. |
| Manufacturer Address | 22 TERRY AVENUE 22 TERRY AVENUE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-26 |