MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-10 for KUHN FRONTAL SEEKER PROBE 629825 manufactured by Karl Storz Endoscopy-america, Inc..
[26877]
Ball on end of probe broke off. Foreign body has not been retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-1996-00008 |
| MDR Report Key | 33800 |
| Date Received | 1996-05-10 |
| Date of Report | 1996-05-08 |
| Date of Event | 1996-04-26 |
| Date Facility Aware | 1996-05-06 |
| Report Date | 1996-05-08 |
| Date Reported to FDA | 1996-05-08 |
| Date Reported to Mfgr | 1996-05-08 |
| Date Added to Maude | 1996-07-02 |
| 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 |
| 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 | KUHN FRONTAL SEEKER PROBE |
| Generic Name | SINUS PROBE |
| Product Code | FGM |
| Date Received | 1996-05-10 |
| Model Number | NA |
| Catalog Number | 629825 |
| Lot Number | KQ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 24 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35150 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | MITTELSTR 8 TUTTLINGER GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-05-10 |