MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-12-09 for OLYMPUS CF-Q160S NA manufactured by Olympus Optical Co., Ltd..
[581172]
The hospital reported they experienced a total loss of image during a procedure. 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
[8056377]
The device in question was returned to olympus for investigation. The investigation revealed evidence of fluid invasion in the electrical connector and body control unit which most likely caused the user's experience. Olympus attributed these phenomenons to improper reprocessing of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2004-10054 |
| MDR Report Key | 793968 |
| Report Source | 05 |
| Date Received | 2004-12-09 |
| Date of Report | 2004-04-22 |
| Date Mfgr Received | 2004-04-22 |
| Date Added to Maude | 2006-12-15 |
| 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 | 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 | 2004-12-09 |
| Model Number | CF-Q160S |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 781586 |
| Manufacturer | OLYMPUS OPTICAL CO., LTD. |
| Manufacturer Address | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME TOKYO JA 163-91 |
| 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 | 2004-12-09 |