MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-14 for UNKNOWN 27068M manufactured by Karl Storz.
[10265]
Piece of instrument broke off in patient's bladder. Doctor retrieved without difficulty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17559 |
| MDR Report Key | 17559 |
| Date Received | 1994-07-14 |
| Date Facility Aware | 1994-03-03 |
| Report Date | 1994-03-10 |
| Date Reported to Mfgr | 1994-03-10 |
| Date Added to Maude | 1994-11-14 |
| 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 | UNKNOWN |
| Generic Name | URETHROTOME BLADE |
| Product Code | EZO |
| Date Received | 1994-07-14 |
| Catalog Number | 27068M |
| Device Expiration Date | 1995-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17480 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | 10111 W. JEFFERSON BLVD. CULVER CITY CA 902323578 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-07-14 |