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 2017-04-28 for SINGLE USE INJECTOR NM-400U-0425 manufactured by Olympus Medical Systems Corp..
[73907174]
The subject device referenced in this report has not yet been returned to olympus for evaluation. Therefore the exact cause of the reported event could not be conclusively determined at this time. If additional information or the subject device is received at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[73907175]
During a mucosectomy, the subject device was used. During procedure, the needle of the subject device was not retracted into the tube. The procedure was completed with a spare device of the same model. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[113939080]
This is a supplemental report for mfr report # 8010047-2017-00527 to provide additional information based on the evaluation result of the subject device. The subject device was returned to olympus medical systems corp. (omsc). As a result of the evaluation on (b)(6) 2017, it was confirmed that the needle of the subject device could not be extended from the sheath. The sheath of the subject device was buckled at 890 mm from distal end. The device history record for the lot indicated no abnormality with the event-related items below. Retracted length of the needle. Length of the sheath. The needle extension/retraction. Extended length of the needle. Based on the similar cases in the past, the needle might be unable to retract into the sheath due to the large friction between the sheath and the needle after the sheath was buckled. The sheath might be buckled, because excessive load was applied to the sheath when the subject device was inserted into the endoscope, when it was taken out from the sterile package, or when 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. 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
| Report Number | 8010047-2017-00527 |
| MDR Report Key | 6529136 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-28 |
| Date of Report | 2017-06-21 |
| Date of Event | 2017-04-13 |
| Date Mfgr Received | 2017-06-02 |
| Device Manufacturer Date | 2016-12-05 |
| Date Added to Maude | 2017-04-28 |
| 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 | BIOMEDICAL ENGINEER |
| 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 |
| Manufacturer Country | US |
| 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 | 2017-04-28 |
| Returned To Mfg | 2017-06-01 |
| Model Number | NM-400U-0425 |
| Lot Number | K6Z05 |
| ID Number | 04953170382284 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-04-28 |