MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-06 for OLYMPUS OLYMPUS EXERA manufactured by Olympus.
[4242863]
Patient having laparoscopic procedure. Patient was prepped and general anesthesia had been administered. Camera was turned on and the color display activated like it normally does; camera was plugged in but no picture display appeared.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034888 |
| MDR Report Key | 3675364 |
| Date Received | 2014-03-06 |
| Date of Report | 2014-03-06 |
| Date of Event | 2014-03-04 |
| Date Added to Maude | 2014-03-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | OLYMPUS EXERA CAMERA 10MM |
| Product Code | KQM |
| Date Received | 2014-03-06 |
| Returned To Mfg | 2014-03-06 |
| Model Number | OLYMPUS EXERA |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Manufacturer Address | SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-06 |