MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-12-06 for OLYMPUS OSF-3 NA manufactured by Olympus Optical Co. Ltd..
[201653]
Complaint description: an office physician reported that four pts experienced discomfort and symptoms of colitis following sigmoidoscopy procedures. Medical treatment was required for the four ill pts. Note: when the olympus technical service supervisor visited the office on 11/07/2000, the physician explained that osf-3 was used for the sigmoidoscopy procedures associated with pt infections. On or about 11/28/2000, osf-3 was delivered to the olympus repair center. The physician notified the supervisor that the first osf-3 was not related to the infections as initially reported. Some details of the initial visit and investigation of osf-3 are being provided as background.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2000-00096 |
| MDR Report Key | 307871 |
| Report Source | 07 |
| Date Received | 2000-12-06 |
| Date of Report | 2000-11-07 |
| Date Mfgr Received | 2000-11-07 |
| Date Added to Maude | 2000-12-11 |
| 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 DR |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 6318445688 |
| 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 | 2000-12-06 |
| Returned To Mfg | 2000-11-28 |
| 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 | 297867 |
| 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. Required No Informationntervention | 2000-12-06 |