MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-11 for ENDOPLUS/SNOWDEN PENCER 88-8233 manufactured by Endoplus.
| Report Number | 1423714-2020-00003 |
| MDR Report Key | 9694344 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-11-18 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-11 |
| 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 | MRS. TRACEY GUDEMAN |
| Manufacturer Street | 750 TOWER ROAD SUITE A |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8473255660 |
| Manufacturer G1 | ENDOPLUS |
| Manufacturer Street | 750 TOWER ROAD SUITE A |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPLUS/SNOWDEN PENCER |
| Generic Name | SLIDE LOCK ATRAUMATIC GRASPER DOUBLE ACTION 5MM |
| Product Code | HET |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2020-01-31 |
| Model Number | 88-8233 |
| Catalog Number | 88-8233 |
| Lot Number | NONE PRESENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOPLUS |
| Manufacturer Address | 750 TOWER ROAD SUITE A MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |