MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-04-26 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..
[107197063]
The device was returned to olympus for evaluation on (b)(6) 2018. The evaluation confirmed the reported device issue. The distal end probe tip was found broken off. In addition, the probe insulation was found in critical condition. The scope was serviced and returned to the user facility. 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 completed. Based on the device evaluation results and similar reported events, the cause of the reported device issue could be attributed to improper maintenance of the device. The instruction manual states,? The probability of failure of the endoscope and ancillary equipment increases as the number of procedures performed and/or the total operating hours increase. 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.? This report will be supplemented if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[107197064]
Olympus was informed that during an unspecified procedure, the tip of the scope broke off and fell inside the patient? S lung. It is unknown if the device fragment was retrieved from the patient. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00277 |
| MDR Report Key | 7465508 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-04-26 |
| Date of Report | 2018-06-20 |
| Date of Event | 2018-04-06 |
| Date Mfgr Received | 2018-04-26 |
| Date Added to Maude | 2018-04-26 |
| 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 | 2018-04-26 |
| Returned To Mfg | 2018-04-06 |
| 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 | 2018-04-26 |