MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-10-07 for CUSA EXCEL CONSOLE CUSAEXCEL manufactured by Valleylab.
[16299263]
The physician was performing a brain tumor resection. The doctor was using the 36 khz handpiece and it was reported that the handpiece overheated causing the optical nerve of the pt to get burnt. The left pupil was less reactive after surgery and the pt had a left peripheral field deficit. A day after the surgery the doctor noted that the pt's vision was improving. The pt was discharged 6 days later with no physical therapy recommended. The pt was stable and doing well. The hospital tested the system three times, once in 2004 and twice the next day and found that the equipment was fully operational.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222895-2004-00006 |
| MDR Report Key | 547665 |
| Report Source | 07 |
| Date Received | 2004-10-07 |
| Date of Report | 2004-09-09 |
| Date of Event | 2004-09-09 |
| Date Mfgr Received | 2004-09-09 |
| Date Added to Maude | 2004-10-12 |
| 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 | JOANN TOMCZYK |
| Manufacturer Street | 22 TERRY AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7815651284 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSA EXCEL CONSOLE |
| Generic Name | ULTRASONIC ASPIRATOR |
| Product Code | LBK |
| Date Received | 2004-10-07 |
| Model Number | CUSAEXCEL |
| Catalog Number | CUSAEXCEL |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 537093 |
| Manufacturer | VALLEYLAB |
| Manufacturer Address | 5920 LONGBOW DR BOULDER CO 80301 US |
| Baseline Brand Name | CUSA EXCEL CONSOLE |
| Baseline Generic Name | ULTRASONIC ASPIRATOR |
| Baseline Model No | CUSAEXCEL |
| Baseline Catalog No | CUSAEXCEL |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K981262 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-07 |