MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-27 for KARL STORZ 27069K manufactured by Karl Storz Gmbh & Co. Kg.
[316984]
The urethrotome broke off during a procedure. It took a while for the surgeon to retrieve the broken piece and control the bleeding. Pt was hospitalized overnight and released the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-2003-00022 |
| MDR Report Key | 493347 |
| Date Received | 2003-10-27 |
| Date of Report | 2003-10-24 |
| Date of Event | 2003-09-30 |
| Date Facility Aware | 2003-09-30 |
| Report Date | 2003-10-24 |
| Date Reported to FDA | 2003-10-24 |
| Date Reported to Mfgr | 2003-10-24 |
| Date Added to Maude | 2003-11-05 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | KARL STORZ |
| Generic Name | URETHROTOME BLADE |
| Product Code | EZO |
| Date Received | 2003-10-27 |
| Model Number | 27069K |
| Catalog Number | 27069K |
| Lot Number | MI-21257 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1.5 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 482052 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | MITTLESTRASSE 8 POSTFACH 230 TUTTLINGEN GM 78503 |
| Baseline Brand Name | KARL STORZ |
| Baseline Generic Name | URETHROTOME KNIFE |
| Baseline Model No | 27069K |
| Baseline Catalog No | 27069K |
| Baseline ID | NA |
| Baseline Device Family | KNIFE |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K934730 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-10-27 |