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 2018-01-10 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[96929740]
The scope has not been returned to olympus for evaluation. A review of the instrument service history was performed and found that the scope was purchased on (b)(6) 2015 and was last serviced at olympus on november 22, 2016. As part of our investigation, an olympus endoscopy support specialist (ess) was dispatched to the user facility on december 18, 2017. There were several reprocessing deviations noted during the ess? Visit: the user facility was not pre-cleaning the scopes. Leak testing was not done properly. The user facility would remove the leak tester from the scopes while still submerged in water. The user facility uses non olympus cleaning brushes. In addition, the facility does not use a channel opening brush and a balloon brush as recommended in the reprocessing manual. The ess provided a wall chart and addressed the reprocessing deviations with the user facility? S staff. To add, a field service engineer (fse) was dispatched to the user facility on december 20, 2017 to check the oer-pro and found no problems with the oer-pro machine. The cause of the reported event could not be conclusively determined; however, based on the ess findings, improper maintenance and reprocessing of the scopes could not be ruled out as contributory factors to the reported events. The reprocessing manual provides several warning and caution statements in an effort to prevent cross contamination, patient infection, and equipment damage. ? Failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each examination can compromise patient safety. To minimize the risk of transmitting diseases from one patient to another, after each examination the endoscope must undergo thorough manual cleaning followed by high-level disinfection or sterilization. Clean the endoscope and accessories thoroughly before disinfection or sterilization to remove microorganisms or organic material that could reduce the efficacy of disinfection or sterilization. Never connect or disconnect the water-resistant cap or the leakage tester? S connector cap while immersed. Doing so could allow water to enter the endoscope and equipment damage can result.? If additional information becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[96929741]
Olympus was informed that 23 patients? Bronchoalveolar lavage (bal) samples tested positive for mycobacterium chelonae. A total of 19 bronchoscopes were reportedly used to examine the patients; however, the user facility did not provide specific information regarding the model/serial number of bronchoscopes used on patients. The user facility further reported that some patients have undergone multiple procedures and in one procedure some patients were examined by multiple bronchoscopes. It is unknown if the positive bal samples are due to the pre-existing condition of the patients or due to unspecified laboratory issues. The user facility reported that the bronchoscopes were pre-cleaned with a detergent. Additionally, leak test was performed during manual cleaning using an olympus leak tester. The bronchoscopes were reprocessed in an olympus automated endoscope reprocessor (aer) machine. There are no problems noted with the aer. All reprocessing staff is properly trained. The scope is hung in a ventilated cabinet. This is report 12 of 23.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00022 |
| MDR Report Key | 7181220 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-10 |
| Date of Report | 2018-01-10 |
| Date Mfgr Received | 2017-12-14 |
| Date Added to Maude | 2018-01-10 |
| 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 | RESPIRATORY THERAPIST |
| 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 | 2018-01-10 |
| Model Number | BF-UC180F |
| Catalog Number | BF-UC180F |
| Lot Number | N/A |
| ID Number | 04953170356360 |
| 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 | 1. Other | 2018-01-10 |