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 |