MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2007-02-15 for SELECTOR INTEGRA USA * 1530000M3 manufactured by Integra Neurosciences, Ltd..
[606690]
A consignment unit was delivered to the hospital by sales rep. It has been reported that the aspiration on the equipment did not work properly when connected. The handpiece also presented with problems. The surgeon performed the frontal lobe tumor removal procedure using surgical instruments and or aspiration since the selector was not functioning properly. The surgery went well and there was no impact to the pt.
Patient Sequence No: 1, Text Type: D, B5
[7871525]
To date, the involved device has not been received for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010219-2007-00004 |
| MDR Report Key | 836552 |
| Report Source | 06,07 |
| Date Received | 2007-02-15 |
| Date of Report | 2007-02-12 |
| Date Mfgr Received | 2007-01-18 |
| Date Added to Maude | 2007-04-13 |
| 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 | 0 |
| Manufacturer Contact | LINDA GOODSTEIN |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362269 |
| Manufacturer G1 | INTEGRA NEUROSCIENCES, LTD |
| Manufacturer Street | NEWBURY RD |
| Manufacturer City | ANDOVER SP104DR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | SP104DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SELECTOR INTEGRA USA |
| Generic Name | ULTRASONIC ASPIRATOR |
| Product Code | LBK |
| Date Received | 2007-02-15 |
| Model Number | * |
| Catalog Number | 1530000M3 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 823847 |
| Manufacturer | INTEGRA NEUROSCIENCES, LTD. |
| Manufacturer Address | * ANDOVER UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-15 |