MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-03-11 for SINGLE USE INJECTOR NM-400U-0423 manufactured by Olympus Medical Systems Corp..
[102111190]
The subject device was returned to olympus medical systems corp. (omsc) for evaluation. The needle was extended from the outer tube. The outer tube was kinked. 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, it was known that the frictional resistance between the outer tube and the needle tube increased due to the kinks, and then the needle could not be retracted into the outer tube. Also, the kinks of the outer tube occurred due to applying bending load to the outer tube when the subject device was inserted into the endoscope, it was taken out from the sterile bag, or pre-use inspection was performed. The instruction manual of the device has already warned as follows; 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
[102111191]
During a colorectal polypectomy, the needle of the subject device could not be retracted into the outer tube. The intended procedure was completed with another device. No patient injury was reported. This is the report regarding the failure of retracting needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-00409 |
| MDR Report Key | 7329908 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-03-11 |
| Date of Report | 2018-03-12 |
| Date of Event | 2018-02-23 |
| Date Mfgr Received | 2018-02-27 |
| Device Manufacturer Date | 2017-07-13 |
| Date Added to Maude | 2018-03-11 |
| 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 |
| Generic Name | INJECTOR AND SHEATHSET |
| Product Code | FBK |
| Date Received | 2018-03-11 |
| Returned To Mfg | 2018-03-02 |
| Model Number | NM-400U-0423 |
| Lot Number | K7713 |
| 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 | 2018-03-11 |