MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-11-28 for OLYMPUS OES CYSTONEPHROFIBERSCOPE CYF-5 manufactured by Olympus Medical Systems Corporation.
[2451245]
Olympus was informed that during an unidentified procedure, material had peeled off the bending section cover when the cystonephrofiberscope was placed in the pt. There was no pt harm reported.
Patient Sequence No: 1, Text Type: D, B5
[9677714]
Olympus followed up with the user facility via phone and in writing, but did not receive any detailed info regarding the reported event. The device was reported to have been previously serviced by an unk third party. The device was returned for eval. The eval confirmed that a portion of the bending section was torn and missing. There was peeling and evidence of chemical damage on the insertion tube. Deep scratches were found on the distal end, but they were determined not to be sharp. The device has been refurbished. If significant additional info is received, this report will be updated. 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 | 8010047-2011-00301 |
| MDR Report Key | 2401177 |
| Report Source | 06 |
| Date Received | 2011-11-28 |
| Date of Report | 2011-10-31 |
| Date of Event | 2011-10-31 |
| Date Mfgr Received | 2011-10-31 |
| Date Added to Maude | 2012-04-19 |
| 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 | BIOMEDICAL ENGINEER |
| 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 HACHIOJI-SHI |
| Manufacturer City | TOKYO 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 OES CYSTONEPHROFIBERSCOPE |
| Generic Name | CYSTONEPHROFIBERSCOPE |
| Product Code | GCQ |
| Date Received | 2011-11-28 |
| Model Number | CYF-5 |
| Catalog Number | CYF-5 |
| 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 TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-28 |