MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-26 for SINGLE USE INJECTOR NM-400U-0525 manufactured by Olympus Medical Systems Corp..
[78384010]
The subject device was returned to olympus medical systems corp. (omsc) for evaluation. The needle tube of the subject device was not retracted. There was kinked on the sheath of the subject device. As the result of checking the manufacturing record of the same lot, there was nothing abnormal found. Based on the evaluation result and similar cases in the past, the needle tube might be unable to retract into the sheath 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, when it was taken out from the sterile package, or when it was checked before use. 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. *stop using the instrument if the insertion portion bends excessively during use. This could result in malfunction, such as failing to extend the needle or inject a fluid.
Patient Sequence No: 1, Text Type: N, H10
[78384011]
When beginning of an unspecified diagnostic, the needle tube of the subject device could not be extended and retracted from the sheath of the subject device. On june 2, 2017, olympus medical systems corp. (omsc) confirmed that the needle tube of the subject device was not retracted into the sheath of the subject device. During the procedure, the subject device might be withdrawn from the endoscope while the needle tube was not retracted into the sheath. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00776 |
| MDR Report Key | 6666600 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-26 |
| Date of Report | 2017-06-27 |
| Date Mfgr Received | 2017-06-02 |
| Device Manufacturer Date | 2016-09-01 |
| Date Added to Maude | 2017-06-26 |
| 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 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 | 2017-06-26 |
| Returned To Mfg | 2017-06-01 |
| Model Number | NM-400U-0525 |
| Lot Number | K6901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-26 |