MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-04-25 for SINGLE USE INJECTOR NM-401L-0423 manufactured by Olympus Medical Systems Corp..
[73560339]
The subject device was returned to olympus medical systems corp. (omsc) for evaluation. The needle tube of the subject device could not be retracted into the sheath. The sheath was kinked. As the result of checking the manufacturing record of the same lot, there was nothing abnormal found. Based on the similar cases in the past, the needle tube might remain extended from the sheath because the sheath was kinked. Also, 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 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. *before use, inspect the insertion portion and the tube for damage.
Patient Sequence No: 1, Text Type: N, H10
[73560340]
During an unspecified therapeutic, it was reported that the needle tube of the subject device was not extended from the sheath of the subject device. The intended procedure was completed with another device. No patient injury was reported. On april 5, 2017, olympus medical systems corp. (omsc) confirmed that the needle tube could not be retracted into the sheath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00490 |
| MDR Report Key | 6517956 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-25 |
| Date of Event | 2017-03-03 |
| Date Mfgr Received | 2017-04-05 |
| Device Manufacturer Date | 2015-12-02 |
| Date Added to Maude | 2017-04-25 |
| 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 | 2017-04-25 |
| Returned To Mfg | 2017-04-04 |
| Model Number | NM-401L-0423 |
| Lot Number | K5Z02 |
| ID Number | 04953170382338 |
| 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 | 2017-04-25 |