MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2007-11-29 for OLYMPUS HPU-20 manufactured by Olympus Medical Systems Corporation.
[766053]
The user facility reported that during a therapeutic gastrointestinal procedure, there was no water feeding from the tip of the heat probe while the pt was bleeding. The bleeding was said to have contained with the use of a different, but similar heat probe and heat probe unit. The procedure was completed and there was no pt injury reported. The user facility claimed that their biomedical engineer dept tested the device after the procedure and was able to duplicate their report.
Patient Sequence No: 1, Text Type: D, B5
[8012535]
The device referenced in this report was returned to olympus for investigation. The investigation did not duplicate the user's report of no water feeding after the device was tested for several hours with no problems found. The device passed all the functional tests. The cause of the user's experience cannot be conclusively determined. However, the heat probe or water pump, which was not returned to olympus for investigation, cannot be ruled out as contributing factors to the user's experience. This report is being filed as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00194 |
| MDR Report Key | 955206 |
| Report Source | 00,06 |
| Date Received | 2007-11-29 |
| Date of Report | 2007-10-31 |
| Date Added to Maude | 2008-03-10 |
| 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 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 | HEAT PROBE UNIT |
| Product Code | FGM |
| Date Received | 2007-11-29 |
| Model Number | HPU-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 951573 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU 1-CHOME TOKYO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-29 |