MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for OLYMPUS EBUS BALLOON manufactured by Olympus Medical Systems Corporation.
[176952935]
While physician was performing an ebus (endobronchial ultrasound), the balloon on the end of the scope came off and was in the pt's airway. The pt was under general anesthesia and was unaware. The balloon was visualized the entire time and was easily removed using forceps. Staff have reached out to the olympus rep and he has had no other reports of this happening and gave some ideas as to why it may have happened. No harm reached the pt. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092563 |
| MDR Report Key | 9641476 |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-16 |
| Date Added to Maude | 2020-01-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS EBUS BALLOON |
| Generic Name | ULTRASOUND BRONCHOSCOPE |
| Product Code | PSV |
| Date Received | 2020-01-28 |
| Lot Number | 2019029 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-28 |