MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,foreign,health professi report with the FDA on 2014-07-21 for OJEMAN CORTICAL STIMULATOR OCS2 manufactured by Integra Burlington, Ma, Inc..
[4879675]
The product was tested by the customer and the results were the following: at the lower impedances, the error was not seen. However, as the impedance increases to a more realistic level, an error was noted. The unit stopped indicating the current and any stimulation when the out voltage reached 40v. It continued to deliver the current with no indication that it was doing so. The meter was set to overload, the green led current indicator stopped flashing, and the audible click stopped. But the unit still delivered the current through the output probe which could be increased and seen to increase on the oscilloscope via the range knob on the unit. There was no pt involved. There was no injury.
Patient Sequence No: 1, Text Type: D, B5
[11987912]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
[41740756]
Additional information was received with the following: the correct serial number of the involved device is serial number (b)(4) (previously provided by the reporter as (b)(4)) integra has completed their internal investigation on 3/23/2016. The investigation included: methods: evaluation of actual device, review of device history records, review of complaint history. Results: the technician observed that neither the power transformer nor the capacitor (c-7) was functioning. Malfunction of either of these two components would prevent the ocs2 from functioning properly. The device passed all qc and final inspection tests before the product was returned to the customer. There was no trend on this complaint for this issue for past complaints. The customer's complaint was not duplicated, however, issues with electrical components (transformer and capacitor) were noted. Both components were not functioning entirely. Without these two components functioning a root cause cannot be assessed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2014-00015 |
| MDR Report Key | 4016060 |
| Report Source | 01,05,FOREIGN,HEALTH PROFESSI |
| Date Received | 2014-07-21 |
| Date of Report | 2014-09-05 |
| Date of Event | 2014-07-02 |
| Date Mfgr Received | 2016-03-23 |
| Device Manufacturer Date | 2009-08-19 |
| Date Added to Maude | 2014-08-26 |
| 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 | 315 ENTERPRISE DR. |
| 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 | NONE |
| Product Code | GYC |
| Date Received | 2014-07-21 |
| Returned To Mfg | 2014-09-15 |
| 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 | 2014-07-21 |