MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-03 for KARL STORZ 10392E manufactured by Karl Storz Gmbh & Co..
[223921]
During the procedure, a karl storz "jackson" bougie was allegedly used. The plastic tip of the bougie came off in the pt's stomach. The surgeon was unable to retrieve the piece and decided to leave it. Doctor expects that the piece will pass through the pt by itself.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-2001-00011 |
| MDR Report Key | 324524 |
| Date Received | 2001-04-03 |
| Date of Report | 2001-03-27 |
| Date of Event | 2001-03-07 |
| Date Facility Aware | 2001-03-08 |
| Report Date | 2001-03-27 |
| Date Reported to FDA | 2001-03-28 |
| Date Reported to Mfgr | 2001-03-28 |
| Date Added to Maude | 2001-04-09 |
| 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 | "JACKSON" BOUGIE |
| Product Code | FAT |
| Date Received | 2001-04-03 |
| Model Number | 10392E |
| Catalog Number | 10392E |
| Lot Number | IX |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 14 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 313983 |
| Manufacturer | KARL STORZ GMBH & CO. |
| Manufacturer Address | MITTELSTRASSE 8 POSTFACH 230 TUTTLINGEN GM 78503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-04-03 |