MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-31 for PLASMA LOOP WA22706S manufactured by Olympus Corporation.
Report Number | MW5090816 |
MDR Report Key | 9266146 |
Date Received | 2019-10-31 |
Date of Report | 2019-10-29 |
Date of Event | 2019-10-28 |
Date Added to Maude | 2019-11-01 |
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 |
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 | PLASMA LOOP |
Generic Name | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL |
Product Code | FAS |
Date Received | 2019-10-31 |
Returned To Mfg | 2019-10-29 |
Catalog Number | WA22706S |
Lot Number | 1000040033 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | OLYMPUS CORPORATION |
Manufacturer Address | HAMBURG DE US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-10-31 |