MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for OLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR NM-4000-0425 manufactured by Olympus Corporation Of Americas.
[141574263]
Staff unable to prime injector needle with nss. Product was not used on the pt. No harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085689 |
| MDR Report Key | 8496936 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-03-20 |
| Date Added to Maude | 2019-04-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 0 |
| Brand Name | OLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR |
| Generic Name | ENDOSCOPC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY |
| Product Code | FBK |
| Date Received | 2019-04-08 |
| Model Number | NM-4000-0425 |
| Lot Number | 75K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS CORPORATION OF AMERICAS |
| Manufacturer Address | 3500 CORPORATE PKWY CENTER VALLEY PA 180340610 US 180340610 |
| Brand Name | OLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR |
| Generic Name | ENDOSCOPC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY |
| Product Code | FBK |
| Date Received | 2019-04-08 |
| Model Number | NM-4000-0425 |
| Lot Number | 75K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS CORPORATION OF AMERICAS HEADQUARTERS |
| Manufacturer Address | 3500 CORPORATE PKWY CENTER VALLEY PA 180340610 US 180340610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |