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 2018-03-19 for SINGLE USE INJECTOR NM-400U-0423 manufactured by Olympus Medical Systems Corp..
[103277613]
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Therefore, the exact cause of the reported event could not be conclusively determined. The lot number of the subject device is unknown. As a result of checking the manufacturing record for past one year from the incident date,it was found no irregularities. This type of the event is most likely related to the operator's technique. Based on the past similar cases, it was known that the needle could not be extended out from the sheath since the frictional resistance became higher between the outer tube and the inner tube due to the kinked outer tube. The instruction manual of the device has already warned as follows; *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. *always have a spare instrument available in case the primary instrument malfunctions.
Patient Sequence No: 1, Text Type: N, H10
[103277614]
When the user was performing polypectomy during a colonoscopy, two nm-400u-0423 devices were used. In the procedure, the needle of the two devices could not be extended out from the sheath. Therefore, the user discontinued the procedure. There was no patient injury reported. The intended procedure was performed in another day and completed without any problem. This is the report regarding the second of the two devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-00472 |
| MDR Report Key | 7351641 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-19 |
| Date of Report | 2018-03-20 |
| Date of Event | 2018-02-22 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-03-19 |
| 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 | 2018-03-19 |
| Model Number | NM-400U-0423 |
| ID Number | 04953170382277 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-03-19 |