MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-20 for BX53 FRAME BX53F manufactured by Olympus Corporation.
| Report Number | 3004182751-2020-00001 |
| MDR Report Key | 9731306 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-20 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-12-25 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-02-20 |
| 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 | 3 |
| Manufacturer Contact | MR. YASUSHI KANEKO |
| Manufacturer Street | TAKAKURA-MACHI 67-4 |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-0033 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-0033 |
| Manufacturer Phone | 426423459 |
| Manufacturer G1 | - |
| Manufacturer Street | - - |
| Manufacturer City | - |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | - |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BX53 FRAME |
| Generic Name | OPTICAL MAICROSCOPE |
| Product Code | IBJ |
| Date Received | 2020-02-20 |
| Model Number | BX53F |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS CORPORATION |
| Manufacturer Address | SHINJUKU MONOLITH 3-1 NISHI SHINJUKU - KU, TOKYO 163-0914 JA 163-0914 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-20 |