MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-13 for KARL STORZ 27224P manufactured by Karl Storz Gmbh & Co..
[187056]
Pt died of air embolism during a hysteroscopy proceure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-2000-00009 |
| MDR Report Key | 282262 |
| Date Received | 2000-06-13 |
| Date of Report | 2000-06-12 |
| Date of Event | 2000-05-18 |
| Date Facility Aware | 2000-05-25 |
| Report Date | 2000-06-12 |
| Date Reported to FDA | 2000-06-13 |
| Date Reported to Mfgr | 2000-06-13 |
| Date Added to Maude | 2000-06-21 |
| 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 | 0 |
| 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 | CONTINUOUS FLOW PUMP |
| Product Code | FEQ |
| Date Received | 2000-06-13 |
| Model Number | 27224P |
| Catalog Number | 27224P |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7.5 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 273150 |
| Manufacturer | KARL STORZ GMBH & CO. |
| Manufacturer Address | MITTELSTRASSE 8 POSTFACH 230 TUTTLINGEN GM 78503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2000-06-13 |