MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2016-11-09 for SINGLE USE INJECTOR NM-400U-0525 manufactured by Olympus Medical Systems Corp..
[59453091]
The subject device has not been returned to olympus medical systems corp. (omsc) for evaluation. The exact cause could not be conclusively determined. A supplemental report will be submitted, if additional and significant information becomes available at a later time.
Patient Sequence No: 1, Text Type: N, H10
[59453092]
During a polypectomy, the two subject devices were used. It was informed that the doctor additionally applied anesthesia to the patient since the drug solution could not be inject to the tissue with the use of the subject devices. The intended procedure was completed with another device. No patient injury was reported. This is the first of two reports.
Patient Sequence No: 1, Text Type: D, B5
[63702895]
This is a supplemental report for mfr report # 8010047-2016-10046 to provide additional information based on the evaluation of the device. The subject device was returned to olympus medical systems corp (omsc) for evaluation. The subject device could be injected, but the needle tube could not be extended from the sheath. The sheath was kinked. As the result of checking the manufacturing record of the subject device, there was nothing abnormal found. Based on the evaluation, the drug solution might be unable to inject to the tissue, because the needle tube could not be extended. The needle tube might be unable to extend from 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, 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. Cross reference mfr. Report number: 8010047-2016-10045.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2016-10046 |
| MDR Report Key | 6088682 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-11-09 |
| Date of Event | 2016-09-15 |
| Date Mfgr Received | 2016-12-16 |
| Device Manufacturer Date | 2016-02-03 |
| Date Added to Maude | 2016-11-09 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 8142642517 |
| 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 | 2016-11-09 |
| Returned To Mfg | 2016-12-13 |
| Model Number | NM-400U-0525 |
| Lot Number | K6203 |
| 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 | 1. Other | 2016-11-09 |