MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-02 for OLYMPUS 03525 manufactured by Olympus Corp..
[135242]
Pt in or - during porcedure tip of urethrotome blade broke off in the bladder. Broken piece was retrieved without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 238748 |
| MDR Report Key | 238748 |
| Date Received | 1999-09-02 |
| Date of Report | 1999-08-13 |
| Date of Event | 1999-08-06 |
| Date Facility Aware | 1999-08-09 |
| Report Date | 1999-08-13 |
| Date Added to Maude | 1999-09-08 |
| 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 | OLYMPUS |
| Generic Name | URETHROTOME BLADE, STRAIGHT |
| Product Code | EZO |
| Date Received | 1999-09-02 |
| Model Number | 03525 |
| Catalog Number | 03525 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 231348 |
| Manufacturer | OLYMPUS CORP. |
| Manufacturer Address | 4 NEVADA DRIVE LAKE SUCCESS NY 11042 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-09-02 |