MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-17 for OJEMAN CORTICAL STIMULATOR OCS2 manufactured by Integra Burlington, Ma, Inc..
[46583405]
A report was received that on (b)(6) 2015, the ocs2 ojeman cortical stimulator had no output current. It was reported that it was an out of box failure (device was purchased on (b)(6) 2015) and it was unknown if the device was in contact with a patient. When it was tested, there was no output current. The batteries were changed and the battery indicator on the unit was at the highest level. A revision/medical intervention was required however details were not provided at the time of this report. The patient was prepped for surgery and there was delay in surgery due to the product problem however the amount of time was not provided. The device had been used approximately 6-8 times since being purchased and received. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
[53567961]
Integra has completed their internal investigation on 09 aug 2016. The investigation included: methods: evaluation of actual device, review of device history records, review of complaint history. Results: evaluation of device: one oc2 was received in billerica on 05/13/2016. The serial number was reported as being (b)(4) which was incorrect, the correct serial number is (b)(4). A visual inspection of the returned product found visual damage on both the front and back left corners of the ocs2. Customer states the unit has no output reading. This issue is due to the transformer breaking off of the printed circuit board. The printed circuit board cannot be repaired - will require replacement board before calibrating 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. No nonconformance reports were raised during the manufacturing process for these monitors. Manufacture date: dec-2007. A two year complaint look back was performed in trackwise for the ocs2. In the prior two years, 21 complaint, including this complaint, have been received on the ocs2. No additional complaints were received with the reported failure? No output current". No adverse trend is identified at this time. Conclusion: the internal component coming loose was likely caused by physical damage to the unit. The ocs2 was repaired, recalibrated and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2016-00005 |
| MDR Report Key | 5660701 |
| Date Received | 2016-05-17 |
| Date of Report | 2016-04-19 |
| Date of Event | 2006-02-25 |
| Date Mfgr Received | 2016-08-09 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2016-05-17 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER BINA PATEL |
| 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 | 2016-05-17 |
| Returned To Mfg | 2016-05-12 |
| 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 | 22 TERRY AVENUE 22 TERRY AVENUE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-17 |