MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-06-12 for HEAT PROBE UNIT HPU 33100 manufactured by Olympus Corp..
[18597164]
During performance of gastroscopy, water jet system of heat probe unit failed to deliver water. No adverse pt effect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006207 |
| MDR Report Key | 22388 |
| Date Received | 1995-06-12 |
| Date of Event | 1995-05-22 |
| Date Added to Maude | 1995-06-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEAT PROBE UNIT |
| Generic Name | HEAT PROBE UNIT |
| Product Code | FGM |
| Date Received | 1995-06-12 |
| Model Number | HPU |
| Catalog Number | 33100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22523 |
| Manufacturer | OLYMPUS CORP. |
| Manufacturer Address | LAKE SUCCESS NY 110421179 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-06-12 |