MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-12 for OJEMAN CORTICAL STIMULATOR OCS2 manufactured by Integra Lifesciences (ireland) Ltd..
[38763026]
It was reported that the device was not working right. The output was set to 0. 3-0. 4 and it started running by itself. There was no patient contact or injury. There was no patient prepped for surgery nor was there a delay in surgery.
Patient Sequence No: 1, Text Type: D, B5
[40860881]
Integra has completed their internal investigation on 02mar2016. The investigation included: methods: evaluation of actual device; review of device history records; review of complaint history. Results: evaluation of device: the reported? Not working and output is set to 0. 3-0. 4 and it starts running by itself? Could not be duplicated during the evaluation assessment. The evaluation identified the pulse duration was out of spec but this would not caused/contributed to the reported failure. The out of spec assessment concluded the monitor was not product release specification and thus requires the monitor to be recalibrated. 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. There is no service history to be reviewed for ocs2 ojeman cortical stimulator serial number (b)(4). A review of ocs2 complaints was completed using the following key words? Not working? And? Running by itself? In the search criteria. The review encompassed from dates 25-jan-15 to 01-mar-16. A total of (b)(4) complaints were reviewed of which this complaint is the single complaint which contained the search criteria. Additionally the review verified the complaint is a single occurrence for (b)(4) and the facility (b)(6) medical centre. Based on the complaint review, a trend is not identified. 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 | 3006697299-2016-00095 |
| MDR Report Key | 5435140 |
| Date Received | 2016-02-12 |
| Date of Report | 2016-01-21 |
| Date Mfgr Received | 2016-03-02 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2016-02-12 |
| 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 LIFESCIENCES (IRELAND) LTD. |
| Manufacturer City | SRAGH TULLAMORE, CO. OFFALY |
| Manufacturer Country | EI |
| 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 | 2016-02-12 |
| Returned To Mfg | 2016-01-28 |
| 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 LIFESCIENCES (IRELAND) LTD. |
| Manufacturer Address | SRAGH TULLAMORE, CO. OFFALY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-12 |