MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2006-02-17 for OLYMPUS GF-UM160 NA manufactured by Olympus Optical Co. Ltd..
[460300]
The user facility reported they experienced a total loss of image during procedure. The image was ubale to be retrieved. The procedure was completed with the use of another similar device. There was no allegation of harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2006-00018 |
| MDR Report Key | 679274 |
| Report Source | 00,06 |
| Date Received | 2006-02-17 |
| Date of Report | 2006-01-23 |
| Date Mfgr Received | 2006-01-23 |
| Date Added to Maude | 2006-02-28 |
| 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 | 3 |
| 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 | 6318445688 |
| Manufacturer G1 | OLYMPUS OPTICAL CO. LTD. |
| 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 | ULTRASONIC GASTROFIBERSCOPE |
| Product Code | GCQ |
| Date Received | 2006-02-17 |
| Returned To Mfg | 2006-01-23 |
| Model Number | GF-UM160 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 668536 |
| Manufacturer | OLYMPUS OPTICAL CO. LTD. |
| Manufacturer Address | SHINJUKU-KU, 1-CHOME TOKYO JA |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | ULTRASONIC ENDOSCOPE |
| Baseline Model No | GF-UM160 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-17 |