MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-06-19 for OLYMPUS MAJ-1351 NA manufactured by Olympus Medical Systems Corporation.
[20213488]
The user facility reported that during a diagnostic ebus (endoscopic bronchial ultrasound) procedure, the users could not get proper imaging to obtain a biopsy due to the balloons leaking. The users reportedly attempted use of several balloons without success. The users elected to abort the ebus procedure and proceeded to an operative biopsy cervical mediastinoscopy. There was reportedly no patient injury other than an unplanned incision. The patient was discharged from the facility in a stable condition on the same day of the procedure.
Patient Sequence No: 1, Text Type: D, B5
[20399100]
The user facility returned a balloon to olympus for evaluation, which is currently in transit. The cause of the user's experience cannot be conclusively determined at this time. If significant additional information becomes available, a supplemental report will be provided. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2009-00122 |
| MDR Report Key | 1406014 |
| Report Source | 05,06 |
| Date Received | 2009-06-19 |
| Date of Report | 2009-05-21 |
| Date of Event | 2009-05-21 |
| Date Mfgr Received | 2009-05-21 |
| Date Added to Maude | 2009-06-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME |
| Manufacturer City | TOKYO 163-91 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 163-91 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | SINGLE-USE BALLOON |
| Product Code | FFY |
| Date Received | 2009-06-19 |
| Model Number | MAJ-1351 |
| Catalog Number | NA |
| Lot Number | 92H |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME TOKYO 163-91 JA 163-91 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-19 |