MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-06 for * 11582M manufactured by Karl Storz.
[3057604]
Basket would not deploy. The device was given to resource nurse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2895235 |
| MDR Report Key | 2895235 |
| Date Received | 2012-11-06 |
| Date of Report | 2012-11-05 |
| Date of Event | 2012-11-02 |
| Report Date | 2012-11-05 |
| Date Reported to FDA | 2012-11-06 |
| Date Added to Maude | 2013-01-03 |
| 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 | 3 |
| 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 | * |
| Generic Name | DISLODGER, STONE BASKET |
| Product Code | EOX |
| Date Received | 2012-11-06 |
| Model Number | 11582M |
| Catalog Number | * |
| Lot Number | S435B |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | 2131 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-06 |