MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-18 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[133713876]
The scope was returned to olympus (b)(4) and will be shipped to the (b)(6) center in (b)(6). The scope is currently pending evaluation. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported complaint. If additional information becomes available, this report will be updated and supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[133713877]
Olympus was informed that two patients developed infections after undergoing diagnostic endobronchial ultrasound bronchoscopy (ebus) procedures in (b)(6) 2018. One of the two patients (patient2) reportedly expired. The user facility? S ambulatory care manager reported that the patient? S death is under investigation and that cross contamination has not been ruled out as a possible contributing factor. Additionally, the user facility reported that a non-olympus automated endoscopic resprocessor steris 1 is utilized to high level disinfect the subject scope. This is 1 of 2 report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00380 |
| MDR Report Key | 8262980 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-18 |
| Date of Report | 2019-04-30 |
| Date of Event | 2018-11-04 |
| Date Mfgr Received | 2019-04-01 |
| Date Added to Maude | 2019-01-18 |
| 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 | 2019-01-18 |
| Returned To Mfg | 2018-11-22 |
| Model Number | BF-UC180F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-01-18 |