MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-11-23 for OLYMPUS ULTRASOUND BALLOON CUFF MAJ-249 manufactured by Olympus Medical Systems Corporation.
[1759154]
The user facility reported that upon completion of a diagnostic endoscopic ultrasound procedure, when the endoscope was removed from the pt, the staff noticed the balloon had failed and the distal tip of the balloon was missing. Attempts to locate the missing part using a gastrovideoscope were not successful. There was no pt harm reported.
Patient Sequence No: 1, Text Type: D, B5
[8810861]
Olympus followed up with the user facility via telephone and in writing to gather add'l info regarding this report. The user facility reported that immediately at the end of the procedure, they discovered that the balloon was missing. There was no pt injury reported and the procedure was completed using the same device. The pt was re-examined with an unidentified model of olympus endoscope, but the balloon could not be located. The pt did not require any further medical or surgical intervention and the user is reportedly unsure if the balloon has passed. The device referenced in this report was discarded and not returned to olympus for eval. 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 | 8010047-2010-00236 |
| MDR Report Key | 1924984 |
| Report Source | 06 |
| Date Received | 2010-11-23 |
| Date of Report | 2010-10-25 |
| Date of Event | 2010-09-29 |
| Date Added to Maude | 2011-03-10 |
| 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 |
| 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 CORP |
| Manufacturer Street | 2951 ISHIKAWA-CHO HACHIOJI-SHI |
| Manufacturer City | TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS ULTRASOUND BALLOON CUFF |
| Generic Name | BALLOON |
| Product Code | GDB |
| Date Received | 2010-11-23 |
| Model Number | MAJ-249 |
| Catalog Number | MAJ-249 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-23 |