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 2018-12-27 for EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC260FW manufactured by Olympus Medical Systems Corp..
[131593887]
The subject device in this report has not been returned to omsc for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[131593888]
Olympus medical systems corp. (omsc) was informed that four olympus bronchoscopes had been quarantined by the infection control department of the user facility due to detections of microbiological contamination in samples of patients. Olympus followed up with the user facility to obtain the detail of the event. It was reported that the biopsy samples collected from four patients were contaminated with cupriavidus, elizabethkingia miricola, or delftia acidovorans after bronchoscopy using four olympus bronchoscopes at the user facility as follows; first patient: the patient contaminated with cupriavidus after bronchoscopy using bf-1t260 (s/n (b)(4)). Second patient: the patient contaminated with cupriavidus after bronchoscopy using bf-uc260fw (s/n (b)(4)). Third patient: the patient contaminated with delftia acidovorans after bronchoscopy using bf-260 (s/n (b)(4)). Fourth patient: the patient contaminated with delftia acidovorans after bronchoscopy using bf-260 (s/n (b)(4)). The bronchoscopes had been reprocessed using a non-olympus automated endoscope reprocessor (bht) with peracetic acid after manual reprocessing. It was reported that it possibly took up 12 hours for the bronchoscopes to be reprocessed between the bedside cleaning at the user facility and the manual cleaning at a third party decontamination facility. It was reported that the bronchoscopes were packed in the surestore system (non-olympus equipment) at the third party decontamination facility. The surestore system is vacuum pack system that add 5% of hydrogen peroxide inside the endoscope channel. The user facility conducted a microbiological testing for the bf-uc260fw at (b)(6). As a result of testing, no microbe was detected from the sample collected from the bf-uc260fw. The conditions of four patients are currently unknown. This is two of four reports on infection associated with the bf-uc260fw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02595 |
| MDR Report Key | 8201848 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-27 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-11-29 |
| Date Mfgr Received | 2019-01-08 |
| Device Manufacturer Date | 2013-07-12 |
| Date Added to Maude | 2018-12-27 |
| 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 | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Generic Name | ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Product Code | PSV |
| Date Received | 2018-12-27 |
| Model Number | BF-UC260FW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-12-27 |