MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-10 for SINGLE USE INJECTOR NM-401L-0423 manufactured by Olympus Medical Systems Corp..
[79905979]
The subject device in this report has not yet been returned to olympus medical systems corp. (omsc) for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available or if the device is returned at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[79905980]
During a mucosectomy, the needle of the subject device used for the injection of nacl could not be retracted into the tube. The procedure was completed with a similar device. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00846 |
| MDR Report Key | 6699846 |
| Date Received | 2017-07-10 |
| Date of Report | 2017-09-12 |
| Date of Event | 2017-06-29 |
| Date Mfgr Received | 2017-09-11 |
| Device Manufacturer Date | 2016-09-01 |
| Date Added to Maude | 2017-07-10 |
| 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 | PHARMACIST |
| 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 | 0 |
| Brand Name | SINGLE USE INJECTOR |
| Generic Name | INJECTOR AND SHEATHSET |
| Product Code | FBK |
| Date Received | 2017-07-10 |
| Returned To Mfg | 2017-09-08 |
| Model Number | NM-401L-0423 |
| Lot Number | K6901 |
| ID Number | 04953170382338 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-07-10 |