MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2005-07-14 for OLYMPUS CF-Q160S NA manufactured by Olympus Optical Co., Ltd..
[18968428]
The hospital reported they were experiencing intermittent yellow lines in the image until it blacked-out completely. The image was unable to be retrieved. The procedure was completed with the use of another similar endoscope. There was no allegation of harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2005-00072 |
| MDR Report Key | 624518 |
| Report Source | 00,06 |
| Date Received | 2005-07-14 |
| Date Mfgr Received | 2005-06-21 |
| Date Added to Maude | 2005-08-08 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARK GAYLE |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355059 |
| 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 | SIGMOIDOVIDEOSCOPE |
| Product Code | FAM |
| Date Received | 2005-07-14 |
| Returned To Mfg | 2005-06-23 |
| Model Number | CF-Q160S |
| 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 | 614146 |
| Manufacturer | OLYMPUS OPTICAL CO., LTD. |
| Manufacturer Address | SINJUKU-KU, 1-CHOME TOKYO JA |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | SIGMOIDOVIDEOSCOPE |
| Baseline Model No | CF-Q160S |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K954451 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-14 |