MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-02 for CIRCON G-500 CLASSIC SERIES * manufactured by Circon Acmi.
[15607604]
Pt in o. R. Procedure done. Md removed "urethrome. " blade at tip broken off. Unable to retrieve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028611 |
| MDR Report Key | 464621 |
| Date Received | 2003-06-02 |
| Date of Report | 2003-06-02 |
| Date of Event | 2003-05-30 |
| Date Added to Maude | 2003-06-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | CIRCON |
| Generic Name | STRAIGHT COLD KNIFE |
| Product Code | EZO |
| Date Received | 2003-06-02 |
| Model Number | G-500 CLASSIC SERIES |
| Catalog Number | * |
| Lot Number | * |
| ID Number | FAX #203-328-8618 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 453543 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 300 STILLWATER AVENUE STAMFORD CT 06902 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-06-02 |