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 2019-04-24 for RHINO-LARYNGO FIBERSCOPE ENF-XP manufactured by Olympus Medical Systems Corp..
[143454156]
The device was returned to olympus for evaluation. A visual inspection was performed on the returned device and found the scope? S bending section was not in a straight position. There was up and down movement when manipulated; however, the bending section would not straighten which confirmed the user is experience. The distal end was inspected and noted there is metal exposed and metal protruding the bending section cover. The bending section cover was removed and found the scope? S skeleton broken causing the bending section not to be in a straight position. There were kinks noted at the top section of the insertion tube near the bending section. Additionally, the scope? S image was inspected and noted 7 broken fibers (black dots) were found on the image. A review the instrument history showed the scope was purchased on july 8, 2017 and returned for repair december 21, 2017, due to damage on the insertion tube. Based on the evaluation, the user? S complaint was confirmed as the scope? S broken skeleton is likely due to mishandling. The instruction manual provides the user several warnings in the? Important information? Please read before use? Section to mitigate damage to the scope. The related warnings are as follows: do not hit to the distal end of the insertion tube or allow it to strike other objects. The objective lens surface of the distal end is particularly fragile, and vision abnormalities may result. Do not twist or bend the bending section by hands. Equipment damage may result. Do not squeeze the bending section forcefully. The covering of the bending section may stretch or break and cause water leaks.
Patient Sequence No: 1, Text Type: N, H10
[143454157]
Olympus was informed that at the conclusion of a diagnostic endoscopy of the airway, the scope would not straighten and caused the patient? S nose to bleed. The bleeding was minor and subsided on its own. The patient did not require any additional procedures or hospital admission. The procedure was completed with the same device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00769 |
| MDR Report Key | 8547419 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date Mfgr Received | 2019-03-28 |
| Date Added to Maude | 2019-04-24 |
| 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 | 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 | RHINO-LARYNGO FIBERSCOPE |
| Generic Name | RHINO-LARYNGOFIBERSCOPE |
| Product Code | EOB |
| Date Received | 2019-04-24 |
| Returned To Mfg | 2019-04-04 |
| Model Number | ENF-XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-24 |