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 2019-03-21 for BALLOON MAJ-1351 manufactured by Olympus Medical Systems Corp..
[139563929]
The balloon was not returned to olympus for evaluation. Olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result. The cause of the report event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[139563930]
Olympus received a medwatch report which states that a second balloon used on the probe end of a bronchoscope was dislodged either during or immediately after the endobronchial ultrasound bronchoscopy (ebus) procedure. The probe was reinserted and the patient underwent a ct scan to ensure the balloon was not retained; however, this could not be confirmed. The staff also searched the or and the balloon could not be located. According to the medwatch report, the first balloon used failed the fluid integrity test due to a pinhole. The intended procedure was completed with the second balloon. There was no injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00569 |
| MDR Report Key | 8442348 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-02-20 |
| Date Mfgr Received | 2019-02-21 |
| Device Manufacturer Date | 2018-11-07 |
| Date Added to Maude | 2019-03-21 |
| 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | BALLOON |
| Generic Name | BALLOON |
| Product Code | PSV |
| Date Received | 2019-03-21 |
| Model Number | MAJ-1351 |
| Lot Number | 8YK |
| 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 | 2019-03-21 |