MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-16 for ENDOPLUS 95-1049SL manufactured by Endoplus.
| Report Number | 3007208013-2019-00029 |
| MDR Report Key | 8903558 |
| Date Received | 2019-08-16 |
| Date of Report | 2019-10-23 |
| Date of Event | 2019-07-22 |
| Date Mfgr Received | 2019-07-22 |
| Date Added to Maude | 2019-08-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | BRANDI MEATH |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 6159645290 |
| Manufacturer G1 | SYMMETRY SURGICAL INC |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPLUS |
| Generic Name | GRASPER |
| Product Code | HET |
| Date Received | 2019-08-16 |
| Catalog Number | 95-1049SL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOPLUS |
| Manufacturer Address | 750 TOWER RD SUITE A MUDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-16 |