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 2017-06-05 for SINGLE USE INJECTOR NM-401L-0623 manufactured by Olympus Medical Systems Corp..
[76709021]
The subject device has not been returned to olympus medical system corp. (omsc) for evaluation. The exact cause of the reported phenomenon could not be conclusively determined. The device history record for the lot indicated no abnormality with the event-related items below. Injection of the liquid. Needle extension/retraction. No bent, kink, crack and scratch on the tube. Based on the similar cases in the past, it was likely that phenomenon occurred due to the compressive buckling on the needle tube. The compressive buckling on the needle tube was likely caused when the needle was extended because of the large friction between the outer tube and the needle. It was likely that the friction between the outer tube and the needle increased by the following factors. The needle was extended/retracted while the tube was bent at inspection of operation. The slider was abruptly pushed. The buckling of the tube. The instruction manual of the device has already warned as follows; straighten out the instrument before inspecting it. The instrument can be damaged if it is coiled while the handle is operated. Operate the slider slowly, otherwise the tube could buckle. 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. Insert the instrument slowly. Abrupt insertion could damage the endoscope and/or instrument. 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
[76709022]
During a paediatric sclerotherapy, three devices were used. Before using the first device, nothing abnormal was found in the first device outside the endoscope. However the user could not flush when he or she tried to inject in the varix, and the first device was retrieved. The user could not stop bleeding because the ethanolamine was not injected into the patient. Blood product was administered by the anesthesiologist and the surgeon because the patient condition deteriorated. As a result, the procedure time was prolonged. The user continued the procedure with the second device, but the user could not flush like the first device. The procedure was completed with the third device of the same model. It was reported that patient condition was stable. This report describes the first device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00682 |
| MDR Report Key | 6613533 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-05 |
| Date of Report | 2017-06-06 |
| Date of Event | 2017-05-17 |
| Date Mfgr Received | 2017-05-17 |
| Date Added to Maude | 2017-06-05 |
| 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 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 | 2017-06-05 |
| Model Number | NM-401L-0623 |
| Lot Number | 6XK |
| ID Number | 04953170382376 |
| 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 | 1. Other | 2017-06-05 |