MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,user facilit report with the FDA on 2020-01-24 for RHINO-LARYNGOFIBERSCOPE ENF-T3 manufactured by Olympus Medical Systems Corp..
[176215262]
The subject device in this report has not been returned to olympus medical systems corp. (omsc) for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[176215263]
Olympus medical systems corp. (omsc) was informed that during a polypectomy of the left vocal cord using the subject device, the patient had a nose bleeding because the folds and protrusion of the subject device such as the lens damaged the patient's nasal mucosa. The patient complained of nasal pain and discomfort after the procedure. There was no report of additional treatment was performed for the patient. There was no report of further patient injury with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-01013 |
| MDR Report Key | 9626653 |
| Report Source | CONSUMER,FOREIGN,USER FACILIT |
| Date Received | 2020-01-24 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2013-05-14 |
| Date Added to Maude | 2020-01-24 |
| 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 | 2020-01-24 |
| Model Number | ENF-T3 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-24 |