MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-11-30 for SINGLE USE INJECTOR NM-400U-0423 manufactured by Olympus Medical Systems Corp..
[128892105]
The subject device was not returned to olympus medical systems corp. (omsc). The exact cause has been under investigation. A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Patient Sequence No: 1, Text Type: N, H10
[128892106]
For the hemostasis after sphincterotomy, the subject device was used. The needle did not extended from the plastic sheath. The procedure was completed with another device. No patient injury was reported. This is the report regarding the failure of the needle extension.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02326 |
| MDR Report Key | 8118690 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-07-23 |
| Date Mfgr Received | 2018-11-11 |
| Date Added to Maude | 2018-11-30 |
| 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 | SINGLE USE INJECTOR |
| Generic Name | INJECTOR AND SHEATHSET |
| Product Code | FBK |
| Date Received | 2018-11-30 |
| Model Number | NM-400U-0423 |
| Lot Number | K8118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-30 |