MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-05 for LOOP CUTTER FS-5U-1 manufactured by Olympus Medical Systems Corp..
| Report Number | 2951238-2019-01104 |
| MDR Report Key | 8966156 |
| Date Received | 2019-09-05 |
| Date of Report | 2019-09-05 |
| Date of Event | 2019-05-31 |
| Date Facility Aware | 2019-08-08 |
| Report Date | 2019-09-05 |
| Date Reported to FDA | 2019-09-05 |
| Date Reported to Mfgr | 2019-08-08 |
| Date Added to Maude | 2019-09-05 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | LOOP CUTTER |
| Generic Name | LOOP CUTTER |
| Product Code | PTS |
| Date Received | 2019-09-05 |
| Model Number | FS-5U-1 |
| Lot Number | 93K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2019-09-05 |