MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-11-20 for OLYMPUS UNK NA manufactured by Olympus Medical Systems Corporation.
[969877]
The user facility reported that a pt claimed to have passed a right-angle shaped rubberized item an unk number of days following a colonoscopy examination. The procedure was said to have been performed over five years earlier. The pt reportedly experienced continuous digestive problems, including gastroesophageal reflux disease (gerd) following the 2003 procedure, and had voluntarily not sought further medical treatment at the time of the event. The unidentified item was discarded.
Patient Sequence No: 1, Text Type: D, B5
[8139220]
No equipment said to be associated with this report was returned to olympus for investigation. The reporting user facility was not able to identify which endoscope was used during the procedure. If further significant info is obtained, the report will be supplemented. The cause of the user's experience could not conclusively be determined. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2008-00191 |
| MDR Report Key | 1242999 |
| Report Source | 05,06 |
| Date Received | 2008-11-20 |
| Date of Report | 2008-10-27 |
| Date of Event | 2003-06-19 |
| Date Mfgr Received | 2008-10-27 |
| Date Added to Maude | 2009-06-17 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 951311700 |
| Manufacturer Country | US |
| Manufacturer Postal | 951311700 |
| Manufacturer Phone | 4848965688 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | ENDOSCOPE |
| Product Code | FTJ |
| Date Received | 2008-11-20 |
| Model Number | UNK |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 22-2 NISHI-SHINJUKU 1-CHOME, SHINJUKU-KU TOKYO 163-91 JA 163-91 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-20 |