MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-13 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[114800762]
As part of our investigation, olympus followed up with the literature? S author by telephone and in writing in an attempt to gather additional information and was informed that no further information would be provided. The article did not provide specific serial numbers for the 14 scopes that cultured positive; therefore, it is unknown if the device was returned and a review of the instrument? S history could not be performed. Olympus cannot determine the cause of the reported event, but the reported condition of the bronchofibervideoscope and improper reprocessing practices cannot be ruled out as a contributing factor. Endoscopes that fail leak testing can pose an infection control risk. The instruction manual contains several warning statements in an effort to prevent severe equipment damage and patient injury:? In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically. An endoscope with an observed irregularity should not be used, but should be inspected by following section 10. 1,? Troubleshooting guide? On page 141. If the irregularity is still suspected after inspection, contact olympus. Using an instrument that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.?
Patient Sequence No: 1, Text Type: N, H10
[114800763]
Olympus received an article titled? Effectiveness of reprocessing for flexible bronchoscopes and endobronchial ultrasound bronchoscopes.? The article mentions that in 2017 a prospective study was conducted in three large tertiary? Care hospitals (sites a, b, c). The researchers examined 24 (9 therapeutic, 9 pediatric, and 6 ebus) clinically used bronchoscopes after manual cleaning and found that all of the bronchoscopes had some residual contamination. Reportedly, microbial growth was found in 14 fully-reprocessed bronchoscopes, including mold, stenotrophomonas maltophilia, and escherichia coli/shigella spp. Microbial culture samples were collected from ports and distal ends of the scopes using sterile swabs moistened with sterile and deionized water that were placed into transport media and then sent to an independent laboratory for testing. During visual inspection all 24 bronchoscopes were found to have anomalies, including retained fluid; brown, red, or oily residue; scratches; damaged insertion tubes and distal ends; and debris in channels. The user facilities are reported to use medivators advantage plus aers and the water filters at all sites were found to be discolored. According to the authors, reprocessing practices were inferior at two of three sites (site b, c). The article also mentions that damaged and contaminated bronchoscopes were in use at all sites. The use of inappropriate lubricants, de-foaming agents and inadequate reprocessing practices may have contributed to bioburden found on the bronchoscopes. According to the authors, guidelines were followed, high-level disinfection was not effective. To mitigate issues found during the study, the user facilities have taken the following actions: retraining, replacing damaged bronchoscopes, changing aer water filters and irrigation-system tubing, switching to sterilization of bronchoscopes, and utilizing sterile, single-use bronchoscopes. This is report 12 of 14.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00414 |
| MDR Report Key | 7687963 |
| Date Received | 2018-07-13 |
| Date of Report | 2018-07-13 |
| Date Mfgr Received | 2018-06-27 |
| Date Added to Maude | 2018-07-13 |
| 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 | 0 |
| Brand Name | EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Generic Name | ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Product Code | PSV |
| Date Received | 2018-07-13 |
| Model Number | BF-UC180F |
| Catalog Number | BF-UC180F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-13 |