MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-03-20 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[103410114]
The scope was returned to olympus for evaluation. A visual inspection was performed on the returned scope and found the balloon tip on the probe unit broke off and missing. The scope passed the leak test. In addition, the insertion tube was noted to be buckled at the distal end area near the bending cover glue. In addition, the biopsy channel port has deep scratches. The scope was repaired and returned to the user facility. The cause of the reported event could not be conclusively determined as limited information was provided by the user facility. However, based on similar related events, the most probable cause of the reported event is improper handling due to excessive force applied when attaching the balloon.
Patient Sequence No: 1, Text Type: N, H10
[103410115]
Olympus was informed that during a bronchoscopy procedure, a piece of the scope distal end broke off and fell inside the patient? S right lung. The broken piece was retrieved. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00198 |
| MDR Report Key | 7356325 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-20 |
| Date of Report | 2018-03-20 |
| Date of Event | 2018-02-27 |
| Date Mfgr Received | 2018-02-27 |
| Date Added to Maude | 2018-03-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Generic Name | ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Product Code | PSV |
| Date Received | 2018-03-20 |
| Returned To Mfg | 2018-03-01 |
| Model Number | BF-UC180F |
| Catalog Number | BF-UC180F |
| Lot Number | N/A |
| ID Number | 04953170356360 |
| 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 | 2018-03-20 |