MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-05 for ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCR manufactured by Olympus America, Inc..
[113190916]
Olympus co2 machine kept shutting off intermittently during colonoscopy procedure. Model: ucr, (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7663396 |
| MDR Report Key | 7663396 |
| Date Received | 2018-07-05 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-05-04 |
| Report Date | 2018-06-29 |
| Date Reported to FDA | 2018-06-29 |
| Date Reported to Mfgr | 2018-07-05 |
| Date Added to Maude | 2018-07-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSCOPIC CO2 REGULATION UNIT |
| Generic Name | INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE |
| Product Code | FCX |
| Date Received | 2018-07-05 |
| Model Number | OLYMPUS UCR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS AMERICA, INC. |
| Manufacturer Address | 3500 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-05 |