MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-27 for OLYMPUS SIGMOIDOSCOPE * manufactured by Olympus.
[350028]
Channel for air and water blocked on sigmoidoscope. The scope was unable to perform. It had been difficult for the surgeon to place to begin with due to the patient's anatomy which is why he did not want to switch scopes when it was determined that it was a sgmoidoscope and not a gastroscope. This was an isolated incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 497185 |
| MDR Report Key | 497185 |
| Date Received | 2003-10-27 |
| Date of Report | 2003-06-01 |
| Date of Event | 2003-05-01 |
| Date Added to Maude | 2003-11-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | OLYMPUS SIGMOIDOSCOPE |
| Generic Name | SIGMOIDOSCOPE |
| Product Code | FAM |
| Date Received | 2003-10-27 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | SN 2723366 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 485939 |
| Manufacturer | OLYMPUS |
| Manufacturer Address | TWO CORPORATE CENTER DRIVE MELVILLE NY 117473157 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2003-10-27 |