MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-04-29 for VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2 manufactured by Olympus Medical Systems Corp..
[143960163]
The subject device was returned to olympus for evaluation. During the evaluation, it was found that there was a crack in the bending section cover glue at the distal end side of the subject device. The bending section cover glue was also noted to be peeling. The scope passed the leak test. In addition, a review of the scope's instrument history records was reviewed and indicated the scope was purchased on april 16, 2016 with no service records. The exact cause could not be conclusively determined, however, the instruction manual provides the following warnings: do not twist or bend the bending section with your hands. Equipment damage may result. Do not squeeze the bending section forcefully. The covering of the bending section may stretch or break, and it may cause water leaks. As a preventive measure, the instruction manual for use states before each case to prepare and inspect the scope such as inspecting the covering of the bending section for sagging, swelling, cuts, holes or other irregularities.
Patient Sequence No: 1, Text Type: N, H10
[143960164]
Olympus was informed that during the nasal examinations, epistaxis (nose bleeds) occured when the scope was withdrawn from the nasal cavity on 4-5 different patients. It was reported that the distal tip of the scope was described as flared or a bubble in the rubber about 2mm from the distal end. The nose bleeds were reportedly mild and did not last long. There was no treatment required as the nose bleeds subsided with pressure to the patients nose. The intended procedures were completed using the same scope. No patient injuries were reported. In addition, it is unknown if the scope was inspected prior to the procedures. 5 of 5 patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00788 |
| MDR Report Key | 8563121 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-29 |
| Date Mfgr Received | 2019-04-03 |
| Date Added to Maude | 2019-04-29 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISERA RHINO-LARYNGO VIDEOSCOPE |
| Generic Name | RHINO-LARYNGO VIDEOSCOPE |
| Product Code | EOB |
| Date Received | 2019-04-29 |
| Returned To Mfg | 2019-03-20 |
| Model Number | ENF-V2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-04-29 |