MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-11-30 for EXCEL CONSOLE WITH FOOTSWITCH EACH1 CUSAEXCEL manufactured by Integra Lifesciences (ireland) Limited.
[3000702]
"the center notified the distributor of a problem on (b)(6) 2012, regarding a cusa excel which was described as follows; "according to the contract (between the distributor and the hosp), the distributor must complete the repair within 10 days. The distributor has not yet reached the deadline of the service period, however the loss of a pt due to the device will create some problems and the distributor expect the hosp to take the issue to (b)(6). The distributor informed us that he was not able to perform the service for the device because of the lack of some spare parts. " the unit was not in contact with the pt. The unit is defective and therefore could not be used for a pt who required urgent organ transplant. The unit at this hosp requires replacement of cusa excel ultrasonic board assembly ((b)(4)). "
Patient Sequence No: 1, Text Type: D, B5
[10259986]
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
| Report Number | 3006697299-2012-00050 |
| MDR Report Key | 2855612 |
| Report Source | 01,08 |
| Date Received | 2012-11-30 |
| Date of Report | 2012-11-30 |
| Date Mfgr Received | 2012-11-21 |
| Date Added to Maude | 2012-12-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Phone | 6099365560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXCEL CONSOLE WITH FOOTSWITCH EACH1 |
| Generic Name | NONE |
| Product Code | LBK |
| Date Received | 2012-11-30 |
| Catalog Number | CUSAEXCEL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES (IRELAND) LIMITED |
| Manufacturer Address | SRAGH TULLAMORE CO. OFFALY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2012-11-30 |