MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for OLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR NM-400U-0525 manufactured by Olympus Medical Systems Corp..
[144942708]
Equipment malfunction. Needle would not prime and medication could not be injected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086545 |
| MDR Report Key | 8600507 |
| Date Received | 2019-05-09 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-25 |
| Date Added to Maude | 2019-05-10 |
| 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 INJECTOR FORCE MAX SINGLE USE INJECTOR |
| Generic Name | ENDOSCOPIC INJECTION, NEEDLE |
| Product Code | FBK |
| Date Received | 2019-05-09 |
| Model Number | NM-400U-0525 |
| Lot Number | 8ZK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |