MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-12-19 for CUSA EXCEL CONSOLE CUSAEXCEL manufactured by Radionics.
[340647]
The hospital was performing a procedure using the cusa excel with a 36khz handpiece without using a nosecone. The doctor went to hand off the recently used and hot handpiece to hospital employee and the doctor accidently stepped on the footpedal causing a burn to the employee. The hospital believes that it was caused by user error but are doing a thorough investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222895-2003-00010 |
| MDR Report Key | 502302 |
| Report Source | 00 |
| Date Received | 2003-12-19 |
| Date of Report | 2003-12-01 |
| Date Mfgr Received | 2003-12-01 |
| Date Added to Maude | 2003-12-23 |
| 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 | 8004666814 |
| 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 | 2003-12-19 |
| Model Number | CUSAEXCEL |
| Catalog Number | CUSAEXCEL |
| Lot Number | U9L406S |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 491071 |
| Manufacturer | RADIONICS |
| Manufacturer Address | 22 TERRY AVE. BURLINGTON MA 01803 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 | 2003-12-19 |