MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-05 for OLYMPUS PLASMA BAND WA22721S manufactured by Surgical Innovation Center/ Olympus Corporation Of America.
| Report Number | MW5087906 |
| MDR Report Key | 8767811 |
| Date Received | 2019-07-05 |
| Date of Report | 2019-07-02 |
| Date of Event | 2019-06-24 |
| Date Added to Maude | 2019-07-08 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OLYMPUS PLASMA BAND |
| Generic Name | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL |
| Product Code | FAS |
| Date Received | 2019-07-05 |
| Returned To Mfg | 2019-07-02 |
| Model Number | WA22721S |
| Lot Number | 1000026575 |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL INNOVATION CENTER/ OLYMPUS CORPORATION OF AMERICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-05 |