MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-01-20 for OLYMPUS ENDOSCOPE UNK NA manufactured by Olympus Medical Systems Corporation.
[1277591]
The user facility reported that a pt had been admitted to the hospital with symptoms of chemical colitis for an unspecified period of time following an endoscopic exam. The pt was said to have been diagnosed with chemical colitis based upon a ct scan, but was not re-examined endoscopically. The pt was said to have been admitted to the hospital for three days, but has been discharged and was said to be doing fine.
Patient Sequence No: 1, Text Type: D, B5
[8347346]
Olympus followed up with the user facility by phone and in writing to obtain additional detailed info regarding the event, but limited detailed info has been provided to date. The physician reportedly informed the pt that the cause of the colitis was due to insufficient reprocessing, but other staff members reportedly disagreed with this allegation. The user facility declined to return the subject device to olympus for eval. The facility contact person stated that there were no problems with the device and that the log of the automatic endoscope reprocessor (aer) used to process the device showed that a full reprocessing cycle was completed prior to the use of the subject device on the pt. The facility contact person reported that the subject device had been used in subsequent procedures and there have been no problems reported. The cause of the pt's outcome cannot be conclusively determined at this time. An olympus endoscopy support specialist has been dispatched to visit the user facility to provide in-service training on appropriate endoscope reprocessing procedures. If significant additional info becomes available, a supplemental report will be provided. 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 | 8010047-2010-00011 |
| MDR Report Key | 1587494 |
| Report Source | 05,06 |
| Date Received | 2010-01-20 |
| Date of Report | 2009-12-22 |
| Date Mfgr Received | 2009-12-22 |
| Date Added to Maude | 2011-03-16 |
| 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 |
| 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 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS ENDOSCOPE |
| Generic Name | ENDOSCOPE |
| Product Code | GDB |
| Date Received | 2010-01-20 |
| 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 | 2951 ISHIKAWA-CHO HACHIOJI-SHI 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-01-20 |