MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-13 for KARL STORZ 10392A manufactured by Karl Storz Gmbh & Co..
[16264736]
During an esophagus dilation, the tip of the dilator allegedly came off inside the pt. The tip was caught in the tumor and was not retrievable. Pt was brought back the next day and an incision was made to retrieve the piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-2000-00023 |
| MDR Report Key | 300042 |
| Date Received | 2000-10-13 |
| Date of Report | 2000-10-13 |
| Date of Event | 2000-09-21 |
| Date Facility Aware | 2000-09-25 |
| Report Date | 2000-10-13 |
| Date Reported to FDA | 2000-10-13 |
| Date Reported to Mfgr | 2000-10-13 |
| Date Added to Maude | 2000-10-17 |
| 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 | FLEXIBLE BOUGIE DILATOR |
| Product Code | KCD |
| Date Received | 2000-10-13 |
| Model Number | 10392A |
| Catalog Number | 10392A |
| Lot Number | NONE |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 290426 |
| Manufacturer | KARL STORZ GMBH & CO. |
| Manufacturer Address | MITTELSTRASSE 8 POSTFACH 230 TUTTLINGEN GM 75803 |
| Baseline Brand Name | KARL STORZ |
| Baseline Generic Name | KARL STORZ ESOPHAGEAL DILATOR |
| Baseline Model No | 10392A |
| Baseline Catalog No | 10392A |
| Baseline ID | LO |
| Baseline Device Family | DILATOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K946331 |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-10-13 |