MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-31 for OTSC SYSTEM SET 12/6 GC 100.27 manufactured by Ovesco Endoscopy Ag.
| Report Number | 3006696607-2020-00002 |
| MDR Report Key | 9902114 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2019-08-09 |
| Date Added to Maude | 2020-03-31 |
| 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 | MS. THERESA BURKHARDT |
| Manufacturer Street | FRIEDRICH-MIESCHER-STRASSE 9 |
| Manufacturer City | TUEBINGEN 72076 |
| Manufacturer Country | GM |
| Manufacturer Postal | 72076 |
| Manufacturer G1 | OVESCO ENDOSCOPY AG |
| Manufacturer Street | FRIEDRICH-MIESCHER-STRASSE 9 |
| Manufacturer City | TUEBINGEN, 72076 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 72076 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OTSC SYSTEM SET |
| Generic Name | OTSC SYSTEM SET |
| Product Code | PKL |
| Date Received | 2020-03-31 |
| Model Number | 12/6 GC |
| Catalog Number | 100.27 |
| Lot Number | 818014 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OVESCO ENDOSCOPY AG |
| Manufacturer Address | FRIEDRICH-MIESCHER-STRASSE 9 TUEBINGEN, 72076 GM 72076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |