MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-18 for STORZ, KNIFE, DISPOSABLE, COLD 27068K * manufactured by Storz.
[17193693]
Knife utilized to open the uretheral sphincter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2074203 |
| MDR Report Key | 2074203 |
| Date Received | 2011-04-18 |
| Date of Report | 2011-04-18 |
| Date of Event | 2011-03-01 |
| Report Date | 2011-04-18 |
| Date Reported to FDA | 2011-04-18 |
| Date Added to Maude | 2011-05-02 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ, KNIFE, DISPOSABLE, COLD |
| Generic Name | DISPOSABLE KNIFE USED IN UROLOGY PROCEDURES TO OPEN STRICTUR |
| Product Code | EZO |
| Date Received | 2011-04-18 |
| Model Number | 27068K |
| Catalog Number | * |
| Lot Number | EB01 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STORZ |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-18 |