MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-10-18 for SINGLE USE INJECTOR NM600/610 NM-600L-0521 manufactured by Olympus Medical Systems Corp..
[124666282]
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation, because the subject device was discarded by the user. Therefore, the exact cause of the reported event could not be conclusively determined. The manufacturing record was reviewed and found no irregularities. This type of the event is most likely related to the operator's technique. Based on the past similar cases, omsc presumes that the event occurred due to either of the following possible causes. 1) the bending of the tube occurred due to applying bending load to the tube when the device was inserted into the endoscope. The frictional resistance between the tube and the needle tube increased due to the bending of the tube. The needle could not be retracted into the tube. 2) the bending of the tube occurred due to applying bending load to the tube when the device was inserted into the endoscope. The frictional resistance between the tube and the needle tube increased due to the bending of the tube. The jointing part of the needle tube slipped toward the distal end when the slider was pulled. The needle could not be retracted into the tube. The instruction manual of the device has already warned as follows; a) 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. B) 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
[124666283]
During a hemostasis for gastric varices bleeding, the subject device was used. Although the user tried to retract the needle of the subject device, the needle could not be retracted into the tube. The user removed the subject device and endoscope from the patient. The intended procedure was completed. No patient injury was reported. This is the report regarding the inability to retract the needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02007 |
| MDR Report Key | 7976997 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-18 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-10-03 |
| Date Mfgr Received | 2018-10-03 |
| Date Added to Maude | 2018-10-18 |
| 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 NM600/610 |
| Generic Name | INJECTOR AND SHEATHSET |
| Product Code | FBK |
| Date Received | 2018-10-18 |
| Model Number | NM-600L-0521 |
| Lot Number | 65K |
| 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 | 2018-10-18 |