MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for EVIS EXERA II BRONCHOVIDEOSCOPE BF-Q180 manufactured by Olympus Medical Systems Corp..
[183139565]
The service center was informed that four patients contracted a cytomegalovirus infection after undergoing a procedure with the facility? S bronchoscopes. The user facility reported that these were inpatients in the facility? S burn or respiratory care unit. The patient samples were sent an independent laboratory and cultured positive. As a result, the user facility acquired a sample of the disinfectant flushed from the scope; however, the culture results are unknown at this. The samples from the scopes are being retained at the facility and refrigerated. The scopes were taken out service at that time; however may have been put back into service due to limited inventory. The patient? S course of treatment is unknown. This is 2 of 8 reports. As part of our investigation of this report, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess their reprocessing practices and to provide reprocessing training if necessary. To date, the ess visit has not been finalized. The scope is being retained at the user facility at this time. An investigation is ongoing to obtain additional information regarding the reported event. This report is to account for patient 1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2020-00364 |
| MDR Report Key | 9813050 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-21 |
| Date Facility Aware | 2020-02-24 |
| Report Date | 2020-02-24 |
| Date Reported to Mfgr | 2020-02-24 |
| Date Added to Maude | 2020-03-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS EXERA II BRONCHOVIDEOSCOPE |
| Generic Name | BRONCHOVIDEOSCOPE |
| Product Code | EOQ |
| Date Received | 2020-03-10 |
| Model Number | BF-Q180 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-10 |