MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-07-10 for OLYMPUS OSF-3 NA manufactured by The Olympus Optical Co. Ltd.
[21255818]
Two routine flexible sigmoidoscopy examinations were performed in a physicians office on 6/2/00. Following the first procedure the pt went home but called the physician sometime later complaining that he/she was in pain. When the pt returned for examination, the physician noticed a perforation of the sigmoid colon. The pt was admitted to the hosp where a temporary colostomy was performed. The physician mentioned that the pt will have the colostomy reversed at a later date.
Patient Sequence No: 1, Text Type: D, B5
[21552766]
A few hours after the second procedure was completed on 6/12/00, the pt called the physician with complaints of chills, fever and bleeding. The physician did not perform a follow-up examination on the pt - they recommended that the pt be hospitalized for follow up treatment, if necessary. On 6/30/00, the physician stated that although the pt had multiple symptoms, they were unable to determine why the pt became ill.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | 8010047-2000-00040 |
| MDR Report Key | 285342 |
| Report Source | 07 |
| Date Received | 2000-07-10 |
| Date of Report | 2000-06-14 |
| Date of Event | 2000-06-12 |
| Date Mfgr Received | 2000-06-14 |
| Date Added to Maude | 2000-07-13 |
| 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 | 2000-07-10 |
| Returned To Mfg | 2000-06-01 |
| 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 | 276134 |
| Manufacturer | THE OLYMPUS OPTICAL CO. LTD |
| Manufacturer Address | 22-2 NISHI-SHINJUKU SHINJU-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 | 2000-07-10 |
| 2 | 0 | 1. Required No Informationntervention | 2000-07-10 |