MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-09 for GASTROINTESTINAL FIBERSCOPE XQ10-OSF2 manufactured by Olympus Corp..
[13359]
Flexible sigmoidoscopy procedure started and air source valve was leaking - unable to do procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006665 |
| MDR Report Key | 24249 |
| Date Received | 1995-08-09 |
| Date of Report | 1995-07-21 |
| Date of Event | 1995-07-11 |
| Date Added to Maude | 1995-08-10 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GASTROINTESTINAL FIBERSCOPE |
| Generic Name | FIBERSCOPE |
| Product Code | FAM |
| Date Received | 1995-08-09 |
| Model Number | XQ10-OSF2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 24615 |
| Manufacturer | OLYMPUS CORP. |
| Manufacturer Address | LAKE SUCCESS NY 11042 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-08-09 |