MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-26 for OLYMPUS PK MORCELLATOR WA90200A manufactured by Olympus Corporation Of America.
| Report Number | MW5088411 |
| MDR Report Key | 8837581 |
| Date Received | 2019-07-26 |
| Date of Report | 2019-07-22 |
| Date of Event | 2019-06-12 |
| Date Added to Maude | 2019-07-29 |
| 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 PK MORCELLATOR |
| Generic Name | ELECTROSURGICAL CUTTING & COAGULATION |
| Product Code | GEI |
| Date Received | 2019-07-26 |
| Model Number | WA90200A |
| Lot Number | U1707046 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS CORPORATION OF AMERICA |
| Brand Name | PNEUMOLINER |
| Generic Name | CONTAINMENT SYSTEM, LAPAROSCOPIC POWER MORCELLATION, WITH INSTRUMENT PORT |
| Product Code | PMU |
| Date Received | 2019-07-26 |
| Model Number | WA90500US |
| Lot Number | 113202 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS CORPORATION OF AMERICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2019-07-26 |