MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for PENTAX EC38-I10F2 manufactured by Hoya Corporation Pentax Tokyo Office.
| Report Number | 2518897-2020-00063 |
| MDR Report Key | 9800486 |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-04 |
| Date Facility Aware | 2020-02-07 |
| Report Date | 2020-03-06 |
| Date Reported to FDA | 2020-03-06 |
| Date Reported to Mfgr | 2020-03-06 |
| Date Added to Maude | 2020-03-06 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | BIOMEDICAL ENGINEER |
| 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 | 3 |
| Brand Name | PENTAX |
| Generic Name | VIDEO COLONOCOPE - I10 STANDARD |
| Product Code | FDF |
| Date Received | 2020-03-06 |
| Model Number | EC38-I10F2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Manufacturer Address | TSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI TOKYO, 196-0012 JA 196-0012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-06 |