MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-01-29 for OLYMPUS EVIS COLONOVIDEOSCOPE PCF-140L NA manufactured by Olympus Medical Systems Corporation.
[18618638]
The user facility reported having terminated an endoscopic examination, as the pt's anatomy was extremely tortuous. The user facility reported that as the endoscope was withdrawn, an area of superficial irritation was noted on the colon wall that had not been seen upon insertion. The reporter stated that no intervention was needed on behalf of the pt, however, a sharp edge was detected on the distal tip of the device following the procedure. The device was removed from service and sent to olympus for eval.
Patient Sequence No: 1, Text Type: D, B5
[18742615]
Olympus followed up with the user facility regarding the reported event. The user facility reported not to have inspected the physical device prior to use. An olympus field representative has been dispatched to visit the user facility to provide in-service training on appropriate handling and reprocessing of the endoscopes. The device referenced in this report was returned to an olympus service branch for eval. The eval confirmed deep dents and scratches on the distal end cover with a sharp edge, which may have contributed to the reported event. The device also failed electrical leakage testing. The cause of the reported event was determined to be due to physical damage from user mishandling. The device has been repaired and returned to the user facility. The pcf-140l operation manual instructs users to inspect the external surface of the entire insertion tube, including the bending section and distal end for any irregularities prior to each use. The manual further advises users that the device should not be used if any irregularities are observed. 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 | 8010047-2010-00015 |
| MDR Report Key | 1593039 |
| Report Source | 05,06 |
| Date Received | 2010-01-29 |
| Date of Report | 2010-01-04 |
| Date of Event | 2009-12-31 |
| Date Mfgr Received | 2010-01-04 |
| Date Added to Maude | 2010-09-03 |
| 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 EVIS COLONOVIDEOSCOPE |
| Generic Name | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2010-01-29 |
| Returned To Mfg | 2010-01-04 |
| Model Number | PCF-140L |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-01-29 |