MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-25 for RHINO-LARYNGOFIBERSCOPE ENF-T3 manufactured by Olympus Medical Systems Corp..
[143032238]
The device was returned to omsc for evaluation but the evaluation is still in progress. The exact cause of the reported event could not be conclusively determined at this time. If additional information is provided, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[143032239]
Olympus medical systems corp. (omsc) was informed that the user facility aborted a diagnostic procedure since the insertion tube of the subject device broke. The patient had a slight bleeding. According to a picture provided by the reporting person, the coating of the insertion tube partially peeled off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-01841 |
| MDR Report Key | 8548002 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-25 |
| Date of Report | 2019-06-25 |
| Date Mfgr Received | 2019-05-30 |
| Device Manufacturer Date | 2002-09-09 |
| Date Added to Maude | 2019-04-25 |
| 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 | 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 | RHINO-LARYNGOFIBERSCOPE |
| Generic Name | RHINO-LARYNGOFIBERSCOPE |
| Product Code | EOB |
| Date Received | 2019-04-25 |
| Model Number | ENF-T3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-04-25 |