MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-05-08 for OLYMPUS OSF-3 manufactured by Olympus Medical Systems Corp.
[1214631]
The user facility reported that at the outset of a diagnostic procedure, just after the device was inserted, the users could no longer visualize the image. The endoscope was withdrawn from the pt, the device re-tested, and the image was said to be blurry. The users elected to abort the procedure and the pt was said to be re-scheduled for another time. The user facility stated that the pt had not received any anesthesia at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
[8271583]
The device referenced in this report was returned to olympus for eval. The eval did not duplicate the user's report of a complete loss of image. The image was examined and was found to be within specification. However, the eval also noted the distal end cover was cracked, and the unit failed electrical leakage testing. Additionally, the bending section glue and objective lens glue were observed to be cracking and peeling. The cracked distal end cover, and glue were determined to be due to physical damage. The cause of the user's experience could not be conclusively be determined. The device was serviced and returned to the user facility. This report is being submitted as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2009-00086 |
| MDR Report Key | 1439086 |
| Report Source | 06 |
| Date Received | 2009-05-08 |
| Date of Report | 2009-04-10 |
| Date Added to Maude | 2009-10-01 |
| 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 MED SYSTEMS CORP |
| Manufacturer Street | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME |
| Manufacturer City | TOKYO 163-91 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 163-91 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | SIGMOIDOFIBERSCOPE |
| Product Code | FAM |
| Date Received | 2009-05-08 |
| Returned To Mfg | 2009-04-10 |
| Model Number | OSF-3 |
| Lot Number | NA |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP |
| Manufacturer Address | SHINJUKU, TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-08 |