MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[139563551]
As part of our investigation, olympus followed-up with the user facility via telephone and in writing to obtain additional information regarding the reported scope, procedure and patient involved but no information was obtained. The referenced scope was returned to olympus for evaluation. The evaluation confirmed the scope has a break on the bending section area near the distal tip. A visual inspection on the received condition of the scope found the bending section separated approximately 25mm from the distal end; no signs of impact (dents). A small portion of the bending section cover is missing at the same location where the separation of the bending section has occurred. The separation of the bending section has produced sharp edges from the exposed bending section skeleton. Additionally, the balloon channel is detached from the distal end; and both the ccd unit and light guide bundle have visible kinks. The image was observed to have excessive ig breakage with very dim light when the image was displayed on the monitor. The potential cause of the detached and separated bending section can be attributed to excessive force (pulling) is applied to the distal end or bending section. The instruction manual provides warning which states, do not twist, bend or squeeze the bending section forcefully as the covering of the bending section may stretch or break and cause water leaks or equipment damage. As a preventive measure, the instruction manual provides instruction to be sure to prepare another scope endoscope to avoid that the examination will be interrupted due to equipment failure or malfunction. If additional information becomes available, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[139563552]
Olympus was informed that during an endobronchial ultrasound (ebus) procedure, after sampling was performed, there was a visible break noted at the distal tip of the scope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00559 |
| MDR Report Key | 8436918 |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-20 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2019-03-20 |
| 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 | 0 |
| Brand Name | EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Generic Name | ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Product Code | PSV |
| Date Received | 2019-03-20 |
| Returned To Mfg | 2019-02-21 |
| Model Number | BF-UC180F |
| 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 | 2019-03-20 |