MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-01 for OLYMPUS AMERICA PCF 160AL * manufactured by *.
[449338]
When md attempted biopsy an approximate 3" long slender piece of rounded wood with a broken tip on one end and smooth on the other end, came out of the scope. Retrieved by md.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038158 |
| MDR Report Key | 691237 |
| Date Received | 2006-03-01 |
| Date of Report | 2006-02-02 |
| Date of Event | 2006-01-27 |
| Date Added to Maude | 2006-03-27 |
| 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 | 3 |
| 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 | OLYMPUS AMERICA |
| Generic Name | FLEXIBLE ENDOSCOPE |
| Product Code | GCQ |
| Date Received | 2006-03-01 |
| Model Number | PCF 160AL |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 680388 |
| Manufacturer | * |
| Manufacturer Address | P.O. BOX 9058 2 CORPORATE CENTER MELVILLE NY 11747 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-03-01 |