MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-05-11 for OLYMPUS URETERO-RENO VIDEOSCOPE URF-V manufactured by Olympus Medical Systems Corporation.
[2640062]
Olympus was informed that during an unspecified procedure a long skinny foreign material was dislodged from the working channel of the scope and fell inside the pt's kidney. The users reported that the foreign material appeared to be the coating from either the working channel of the endoscope, the laser fiber, the basket or the guidewire. The size of the laser fiber used during the procedure was 365 micron. There was no further info provided.
Patient Sequence No: 1, Text Type: D, B5
[9852603]
Olympus followed up with the user facility to obtain additional info regarding the reported event and was provided with limited info. The user facility staff reported that the user was a private practitioner that performed the procedure in their facility. The user facility staff reported that the foreign material was broken into pieces and was retrieved from the pt's kidney with the user of an unidentified grasping forceps. The foreign materials were sent to pathology lab for analysis. The condition of the pt is unk. No further info provided. The device referenced in this report was returned to olympus for eval. The instrument channel of the device was examined using a baroscope no foreign object or material was found. There was a kink, damage, scrape mark or tear mark found inside the instrument channel. There were no signs of missing parts, or components noted with the device. The bending section was leaking due to a cut. The distal end cover was cracked, peeling and discolored. The bending section mesh was found damaged and bent. This scope will be serviced and returned to the user facility. The exact cause of the user's report could not be conclusively determined. Olympus will continue to work with the user to obtain additional info. If additional and significant info becomes available at a later time, this report will be supplemented. This report is being submitted as a medical device report in an excess of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2012-00147 |
| MDR Report Key | 2577670 |
| Report Source | 06 |
| Date Received | 2012-05-11 |
| Date of Report | 2012-04-13 |
| Date of Event | 2012-04-13 |
| Date Mfgr Received | 2012-04-13 |
| Date Added to Maude | 2012-06-15 |
| 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, 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 URETERO-RENO VIDEOSCOPE |
| Generic Name | URETERO-RENO VIDEOSCOPE |
| Product Code | GCQ |
| Date Received | 2012-05-11 |
| Returned To Mfg | 2012-05-02 |
| Model Number | URF-V |
| Catalog Number | URF-V |
| 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 | 2012-05-11 |