MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-02 for STORTZ URETHROTOME BLADE 27068M * manufactured by Karl Stortz Endoscopy.
[135974]
Sache urethrotome blade snapped off in pt's urethra during urethrotomy. It took add'l operating time to retrieve the blade.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 248520 |
| MDR Report Key | 248520 |
| Date Received | 1999-11-02 |
| Date of Report | 1999-11-01 |
| Date of Event | 1999-10-15 |
| Date Facility Aware | 1999-10-22 |
| Report Date | 1999-11-01 |
| Date Added to Maude | 1999-11-08 |
| 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 | STORTZ URETHROTOME BLADE |
| Generic Name | BLADE |
| Product Code | EZO |
| Date Received | 1999-11-02 |
| Model Number | 27068M |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 240766 |
| Manufacturer | KARL STORTZ ENDOSCOPY |
| Manufacturer Address | 600 CORPORATE POINTE CULVER CITY CA 90230 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-11-02 |