MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-28 for OJEMANN CORTICAL STIMULATOR PROBE (NOT STERILE) OCS2PND manufactured by Integra Neuroscicencs Implants Sa.
[81489782]
The reprocessing instructions were followed exactly; however, a crystallized residual was observed post sterilization seemingly dispersed from the proximal and distal tips of the probe. No patient injury. No revision/medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612007-2017-00022 |
| MDR Report Key | 6750673 |
| Date Received | 2017-07-28 |
| Date of Report | 2017-07-05 |
| Date Mfgr Received | 2017-12-04 |
| Date Added to Maude | 2017-07-28 |
| 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 | USER ROWENA BUNUAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Manufacturer Street | 2905 ROUTE DES DOLINES |
| Manufacturer City | SOPHIA ANTIPOLIS F-06921 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | F-06921 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OJEMANN CORTICAL STIMULATOR PROBE (NOT STERILE) |
| Generic Name | OJEMANN CORTICAL STIMULATOR PROBE |
| Product Code | GYC |
| Date Received | 2017-07-28 |
| Returned To Mfg | 2017-11-20 |
| Catalog Number | OCS2PND |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Manufacturer Address | 2905 ROUTE DES DOLINES 2905 ROUTE DES DOLINES SOPHIA ANTIPOLIS F-06921 FR F-06921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-28 |