MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2007-02-22 for OLYMPUS BF-P160 * manufactured by Olympus Optical Co., Ltd..
[17769725]
The hospital reported that during a diagnostic bronchocopy they experienced a total loss of image. The procedure was completed with a different, but similar device. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[18007271]
The device referenced in this report was returned to olympus for evaluation. Evaluation revealed that the light guide and objective lenses were cracked and chipped respectively, and the plastic cover dented, findings consistent with physical damage of the device. Evidence of fluid invasion was found in the control body unit and leaks were present in both the control body and instrument channel. The investigation also noted worn and cracked glue on the side of the control body unit. The image was confirmed to flicker and disappear intermittently, and the device buttons operated on an intermittent basis. This report is being filed as a mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00021 |
| MDR Report Key | 839821 |
| Report Source | 00,05,06 |
| Date Received | 2007-02-22 |
| Date of Report | 2007-01-25 |
| Date of Event | 2007-01-25 |
| Date Added to Maude | 2007-04-23 |
| 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 | 4848965688 |
| 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 | BRONCHOSCOPE |
| Product Code | ENZ |
| Date Received | 2007-02-22 |
| Model Number | BF-P160 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 827107 |
| Manufacturer | OLYMPUS OPTICAL CO., LTD. |
| Manufacturer Address | SHINJUKU-KU, 1-CHOME TOKOY JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-22 |