MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-22 for DEFENDO SUCTION VALVE 100305 manufactured by Medivators Inc..
| Report Number | MW5088292 |
| MDR Report Key | 8817630 |
| Date Received | 2019-07-22 |
| Date of Report | 2019-07-18 |
| Date of Event | 2019-05-31 |
| Date Added to Maude | 2019-07-23 |
| 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 | DEFENDO SUCTION VALVE |
| Generic Name | ENDOSCOPE CHANNEL ACCESSORY |
| Product Code | ODC |
| Date Received | 2019-07-22 |
| Model Number | 100305 |
| Lot Number | 415963 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS INC. |
| Manufacturer Address | MINNEAPOLIS MN 55447 US 55447 |
| Brand Name | LOOP CUTTER |
| Generic Name | ENDOSCOPIC GRASPING / CUTTING INSTRUMENT, NON-POWERED EXEMPT |
| Product Code | PTS |
| Date Received | 2019-07-22 |
| Model Number | FS-5U-1 |
| Lot Number | 93K |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION/ OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-07-22 |