MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2014-07-09 for SINGLE USE ASPIRATION NEEDLE BA-201SX-4022 NA manufactured by Olympus Medical Systems Corporation.
[4956140]
Olympus medical systems corp (omsc) was informed that a procedure, the sheath was kinked. There was no report of patient injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5
[11985409]
Omsc have not received the subject products for evaluation yet. The exact cause of the user's report could not be conclusively determined. A supplemental report will be submitted, if additional and significant information becomes available at a later time. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2014-00402 |
| MDR Report Key | 4008997 |
| Report Source | 01,07,08 |
| Date Received | 2014-07-09 |
| Date of Report | 2014-06-11 |
| Date of Event | 2014-06-11 |
| Date Mfgr Received | 2014-06-11 |
| Date Added to Maude | 2014-08-25 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 26425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE USE ASPIRATION NEEDLE |
| Generic Name | ASPIRATION NEEDLE |
| Product Code | FZG |
| Date Received | 2014-07-09 |
| Model Number | BA-201SX-4022 |
| Catalog Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-09 |