MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-08-16 for OLYMPUS HPU-20 NA manufactured by Olympus Optical Co. Ltd..
[15491352]
The hospital reported the patient underwent a procedure with cautery for arteriovenous malformations (avms). The procedure was completed and the patient was discharged. The patient came back to the emergency room (er) that evening complaining of abdominal pain, bloating and cramps. The patient was diagnosed as having ileus and received two units of blood. The next day the patient was given two additional units of blood and re-scoped where they found diverticula and avms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2005-00087 |
| MDR Report Key | 627747 |
| Report Source | 05,06 |
| Date Received | 2005-08-16 |
| Date of Report | 2005-07-13 |
| Date of Event | 2005-06-15 |
| Date Mfgr Received | 2005-07-13 |
| Date Added to Maude | 2005-08-19 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARK GAYLE |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355059 |
| Manufacturer G1 | OLYMPUS OPTICAL CO. LTD |
| 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 | 2005-08-16 |
| Model Number | HPU-20 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 617379 |
| Manufacturer | OLYMPUS OPTICAL CO. LTD. |
| Manufacturer Address | SHINJUKU-KU 1-CHOME TOKYO JA |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | HEAT PROBE UNIT |
| Baseline Model No | HPU-20 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2005-08-16 |