MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-06-05 for SINGLE USE INJECTOR NM-400U-0425 manufactured by Olympus Medical Systems Corp..
[76737182]
The subject device referenced in this report has not yet been returned to olympus for evaluation. Therefore the exact cause of the reported event could not be conclusively determined at this time. If additional information or the subject device is received at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[76737183]
During a mucosectomy, the subject device was used. During the procedure, the needle of the subject device was difficult to be removed and the physician could not perform the injection. The physician tried to retract the needle, but the needle could not be retracted into the sheath. The procedure was completed with a spare device of the same model. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00681 |
| MDR Report Key | 6613549 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-05 |
| Date of Report | 2017-07-15 |
| Date of Event | 2017-05-11 |
| Date Mfgr Received | 2017-06-23 |
| Date Added to Maude | 2017-06-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KATSUAKI MORITA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO |
| Manufacturer Country | US |
| 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 | 2017-06-05 |
| Model Number | NM-400U-0425 |
| Lot Number | 71K |
| ID Number | 04953170382284 |
| 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 | 2017-06-05 |