MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-07-10 for LOOP CUTTER FS-5U-1 manufactured by Olympus Medical Systems Corp..
| Report Number | 8010047-2019-02485 |
| MDR Report Key | 8779024 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-07-10 |
| Date of Report | 2019-07-11 |
| Date of Event | 2019-06-10 |
| Date Mfgr Received | 2019-06-18 |
| Device Manufacturer Date | 2018-03-02 |
| Date Added to Maude | 2019-07-10 |
| 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 | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOOP CUTTER |
| Generic Name | LOOP CUTTER |
| Product Code | PTS |
| Date Received | 2019-07-10 |
| Returned To Mfg | 2019-07-01 |
| Model Number | FS-5U-1 |
| Lot Number | K8302 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-10 |