MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-23 for CUSA EXCEL CUSAEXCEL NA manufactured by Valleylab Div Tyco Healthcare Gr.
[401918]
Add'l info rec'd from mfr 11/11/03: the medwatch sent by the customer identified the console, rather than the cusa tip. The cusa tip was not returned to valleylab for eval; however, the handpiece had been returned to valleylab's service dept on july 18th, 2003. The test results found the handpiece to operate properly and within all specs when tested with a spare test tip. The handpiece was disassembled and no conditions were found that would have caused or contributed to the tip breaking. Although the cause of the customer's report cannot be determined, tip breakage is known to occur when the tip is placed in close proximity to electrosurgical energy during use. The tip will produce a bluish color, but again, the tip was not returned for exam. Product labeling cautions the user not to use the tip in close proximity to electrosurgery.
Patient Sequence No: 1, Text Type: D, B5
[21583000]
Tip of the cusa (ultrasounic surgical aspirator) handpiece broke while in use. Tip retrieved, no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029632 |
| MDR Report Key | 488779 |
| Date Received | 2003-09-23 |
| Date of Report | 2003-09-16 |
| Date of Event | 2003-06-21 |
| Date Added to Maude | 2003-10-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSA EXCEL |
| Generic Name | ULTRASONIC SURGICAL ASPIRATOR |
| Product Code | LBK |
| Date Received | 2003-09-23 |
| Returned To Mfg | 2003-06-25 |
| Model Number | CUSAEXCEL |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 477606 |
| Manufacturer | VALLEYLAB DIV TYCO HEALTHCARE GR |
| Manufacturer Address | 5920 LONGBOW DR BOULDER CO 803013299 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 | 2003-09-23 |