MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-30 for OJEMAN CORTICAL STIMULATOR OCS2 manufactured by Integra Burlington, Ma, Inc..
[66336441]
The ocs2 ojeman cortical stimulator was not reading correctly without the probe. When the device was set to start prior to touching the brain the device sounded the buzzer as expected but displayed 1. 26 ma on the display as if there was an impedance across the electrodes? The electrodes were clean and in air. The device was set to stop. The changed the electrode and checked the current and it was still set to 2. 00 ma and the set the switch to start. With only air contacting the electrodes the device still displayed 1. 26 ma. The power indicator showed 2 green bars. The device was switched off and the batteries changes. Three bars were showing. All switches were move and returned to their original settings in case contact had not been made. The stimulation current was once again checked and was 2. 00 ma. The device was set to the start position with the electrodes in free air and the current on the display read 1. 26 ma. The electrodes were unplugged from the unit and it was set to start. The display read 1. 26 ma. Discussions with angus suggested that maybe the electrodes needed an impedance. I asked the surgeon if there was still some tumour on display which we could stimulate. The electrode was placed on the tumour with a set current of 2 ma and the device set to start. The display read 1. 26 ma. Next i removed the electrode from the unit and set the current to 5 ma. I then set the switch to start. The display read 4. 24 ma. It appears that the display was showing the set current? 1 ma. At the end of the case i performed one more test. With the current still set to 5 ma the electrode was place onto cotton balls soaked in ringers solution. The switch was set to start and the display showed 5 ma. When the electrode was removed from the solution the display went to "----" which is the normal display when the electrodes are in free air. From this point on the team could not fault the device. This was evident when it was compared to the unit from the children? S hospital. The problem with this type of fault is that the team was performing an awake craniotomy for a tumour in the motor strip and was relying on the stimulation to help identify the tumour boundary. The failure of the device did not allow this to occur. This fault needs to be investigated as the consequences for failure or intermittent behaviour can have devastating effect.
Patient Sequence No: 1, Text Type: D, B5
[73691034]
Investigation completed 3/07/2017. Method: -dhr review. -trend analysis. -failure analysis. The following job was reviewed for the ocs2; s/n (b)(4), manufacture date: sept. 2011. Job review established that the unit met specifications and internal quality standards prior to release. No inconsistencies identified. A review of complaint database performed and this is the first instance in which a complaint was reported that the ocs2 was not reading correctly without probe. No trends are present at this time. No manufacturing or design related trend has been identified. One ocs2 was received for evaluation. The functional test of the ocs2 has been performed according to manufacturers? Specification. No parts replacement for repair were required. A review of the test inspection form found that all readings measured within specification. Note that the bipolar probe (ocs2pnd) utilized during the reported incident was not returned for evaluation along with the ocs2. The age and condition of the probe was not known. Conclusion: the ocs2 tested to specification. Reported failure could not be duplicated as the ocs2 functioned as intended and within specification. The complaint is considered to be unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2017-00001 |
| MDR Report Key | 6287267 |
| Date Received | 2017-01-30 |
| Date of Report | 2016-11-14 |
| Date Mfgr Received | 2017-03-07 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2017-01-30 |
| 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 ROWENA BUNUAN |
| Manufacturer Street | 22 TERRY AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| 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 | 2017-01-30 |
| Returned To Mfg | 2016-11-23 |
| 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 | 2017-01-30 |