MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-16 for SINGLE USE INJECTOR NM600/610 NM-610L-0423 manufactured by Olympus Medical Systems Corp..
[70171091]
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation, because the subject device was already discarded. The lot no. Was unknown. Therefore, as the result of checking the manufacturing record of the devices which had delivered to the customer during past one year, there was nothing abnormal found. The exact cause could not be conclusively determined. However, based on the similar cases in the past, the needle tube might remain extended from the sheath of the subject device, because the sheath was kinked. The sheath might be kinked, because excessive load was applied to the sheath when the subject device was inserted into the endoscope, it was taken out from the sterile package, or it was checked before use. The instruction manual of the subject device warns; *when inserting the instrument into the endoscope, retract the needle into the sheath, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve. Otherwise, the instrument could be damaged. *before use, inspect the insertion portion and the tube for damage.
Patient Sequence No: 1, Text Type: N, H10
[70171092]
During an endoscopic submucosal dissection, the subject device was used. The user temporarily withdrew the subject device from the endoscope. After that, the doctor tried to insert the subject device into the endoscope again. At the time, the needle tube of the subject device was stuck to the nurse because the needle tube was extended from the sheath of the subject device. The intended procedure was completed with another device. The nurse had the blood test to confirm whether there was infectious disease or not. No abnormalities have been reported about the nurse. The nurse already recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00301 |
| MDR Report Key | 6412190 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-16 |
| Date of Event | 2017-02-20 |
| Date Mfgr Received | 2017-02-22 |
| Date Added to Maude | 2017-03-16 |
| 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 HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 8142642517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE USE INJECTOR NM600/610 |
| Generic Name | INJECTOR AND SHEATHSET |
| Product Code | FBK |
| Date Received | 2017-03-16 |
| Model Number | NM-610L-0423 |
| Device Availability | N |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-16 |