MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-25 for OLYMPUS ERCP SCOPE TJF-Q180V manufactured by Olympus Medical System Corporation.
[125286790]
During ercp procedure, the stent was retained in the endoscope and did not deploy. Notified mfr - olympus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080812 |
| MDR Report Key | 8008851 |
| Date Received | 2018-10-25 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-09-24 |
| Date Added to Maude | 2018-10-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | OLYMPUS ERCP SCOPE |
| Generic Name | ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM |
| Product Code | NWB |
| Date Received | 2018-10-25 |
| Model Number | TJF-Q180V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Address | CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-10-25 |