MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-03-23 for OLYMPUS OSF-3 NA manufactured by Olympus Optical Co., Ltd..
[150506]
A medical office tech reported that two pts were admitted to the hospital with temp, abdominal pain and continuous bloody diarrhea within one day of having a routine endoscopic examination. The tech stated that no abnormalities were detected during the examination. According to the tech, one pt remained in the hospital two days and the other pt was hospitalized for over a week as a result of the occurrences. The tech does not know if pt cultures were taken during their hospitalization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2000-00019 |
| MDR Report Key | 270817 |
| Report Source | 07 |
| Date Received | 2000-03-23 |
| Date of Report | 2000-03-06 |
| Date Mfgr Received | 2000-03-06 |
| Date Added to Maude | 2000-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2 CORPORATE CENTER DRIVE |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 5168445688 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | SIGMOIDOSCOPE |
| Product Code | FAM |
| Date Received | 2000-03-23 |
| Returned To Mfg | 2000-03-01 |
| Model Number | OSF-3 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 262179 |
| Manufacturer | OLYMPUS OPTICAL CO., LTD. |
| Manufacturer Address | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME TOKYO JA 163-91 |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | SIGMOIDOSCOPE |
| Baseline Model No | OSF-3 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2000-03-23 |