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 2018-04-18 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[105876432]
The scope was returned to olympus for evaluation; however, the device evaluation is still in progress and pending results. The scopes will be sent to an independent laboratory for microbial testing and eto sterilization. As part of our investigation, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facility? S reprocessing practice and to provide a reprocessing training. To date, the ess visit has not been finalized. This report will be supplemented when the device evaluation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[105876433]
Olympus was informed by the user facility that an unspecified number of patient bronchoalveolar lavage (bal) washings tested (b)(6) for (b)(6) involving three different olympus bronchoscopes. The patients are fine and have been discharged. It was further reported that the scopes were not cultured. The scopes are pre-cleaned after each procedure in the or. It is then manually cleaned and the channels of the scopes are brushed using a non-olympus halyard single use dual-ended cleaning brush. The scopes are leak tested using an olympus leak tester. The scopes are reprocessed in a non-olympus steris 1e automated endoscope reprocessor (aer) machine. The last preventative maintenance on the aer machine was (b)(6) 2018. No problems reported with the aer machine. The scopes are hung in a ventilated scope cabinet. In addition, it was reported that all of the reprocessing staff are properly trained in reprocessing scopes. This is report 1 of 3.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00249 |
| MDR Report Key | 7442055 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-18 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-03-26 |
| Date Mfgr Received | 2018-06-15 |
| Date Added to Maude | 2018-04-18 |
| 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 | 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 | 2018-04-18 |
| Returned To Mfg | 2018-04-03 |
| Model Number | BF-UC180F |
| Catalog Number | BF-UC180F |
| Lot Number | N/A |
| ID Number | #N/A |
| 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. Other | 2018-04-18 |