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 2019-03-13 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[138706701]
The device was returned to olympus and pending evaluation. Olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but only limited information was provided. As part of our investigation, an olympus endoscopy support specialist was dispatched to observe the user facility? S reprocessing practices and provide training if necessary. To date, the ess visit has not been finalized. A review the instrument history revealed that the scope was purchased (b)(6) 2017 and was last returned for service on april 12, 2018.
Patient Sequence No: 1, Text Type: N, H10
[138706702]
Olympus was informed that the bronchial wash of two patients came back positive for aspergillus (black mold) after undergoing procedures with facility? S bronchoscopes ((b)(4) and (b)(4)). It was reported that one patient underwent procedures with both scopes. The user facility's charge nurse reported that the patients involved were not treated as they were asymptomatic. In addition, the scopes were removed from service as a precaution and cultured negative for any microbial growth. The user facility is currently conducting an internal investigation of the reported events. This 3 of 3 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00533 |
| MDR Report Key | 8417849 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-13 |
| Date of Report | 2019-05-02 |
| Date Mfgr Received | 2019-04-03 |
| Date Added to Maude | 2019-03-13 |
| 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 | EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Generic Name | ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Product Code | PSV |
| Date Received | 2019-03-13 |
| Returned To Mfg | 2019-02-22 |
| Model Number | BF-UC180F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-13 |