MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,07 report with the FDA on 2011-07-15 for OLYMPUS BALLOON 3 FOR ULTRASONIC ENDOSCOPE MAJ-249 5295630 manufactured by Olympus Medical Systems Corp..
[2269607]
Olympus received a medwatch report, which stated: "during a balloon for ultrasonic endoscope procedure, six (6) balloons were put on endoscope and had holes in the same area. Four of the 6 were retrieved. The rest of the bag of 20 were not used and sequestered".
Patient Sequence No: 1, Text Type: D, B5
[9257064]
Olympus followed-up with the user facility via phone and in writing to obtain additional information, however no additional information was provided. The devices reference in this report were not returned to olympus. Review of complaint files identified no other complaints for this lot. The cause of the reported event could not be conclusively determined. Olympus will continue to investigate this matter and this report will be supplemented. 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 | 8010047-2011-00158 |
| MDR Report Key | 2224257 |
| Report Source | 00,06,07 |
| Date Received | 2011-07-15 |
| Date of Report | 2011-06-17 |
| Date of Event | 2011-05-13 |
| Date Mfgr Received | 2011-06-17 |
| Date Added to Maude | 2012-04-18 |
| 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 | 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 |
| Manufacturer City | HACHIOJI-SHI, 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 BALLOON 3 FOR ULTRASONIC ENDOSCOPE |
| Generic Name | BALLOON |
| Product Code | GDB |
| Date Received | 2011-07-15 |
| Model Number | MAJ-249 |
| Catalog Number | 5295630 |
| Lot Number | 13H/2011090 |
| 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 CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-15 |