MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-08-09 for ENDOSCOPIC CO2 REGULATION UNIT UCR manufactured by Olympus Medical Systems Corp..
[51693701]
The device was not returned to olympus for evaluation. The cause of the reported event could not be determined. Olympus made multiple follow ups by telephone and in writing in an attempt to obtain additional information regarding the reported event; however, no additional information was obtained.
Patient Sequence No: 1, Text Type: N, H10
[51693702]
Olympus was informed that the patient's colon was perforated during a colonoscopy procedure. An olympus endoscope (model and serial number unknown) was also used in the procedure. It was also reported that the facility was using non olympus tubing, non olympus valves, and non olympus water bottle with the reported ucr machine. The patient's outcome is unknown. It is also unknown if the procedure was completed. No additional information was provided. This is report 2 of 4.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2016-00677 |
| MDR Report Key | 5858155 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-08-09 |
| Date of Report | 2016-08-09 |
| Date of Event | 2016-07-14 |
| Date Mfgr Received | 2016-07-21 |
| Date Added to Maude | 2016-08-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DONNY SHAPIRO |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-516 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSCOPIC CO2 REGULATION UNIT |
| Generic Name | CO2 REGULATION UNIT |
| Product Code | FCX |
| Date Received | 2016-08-09 |
| Model Number | UCR |
| Catalog Number | UCR |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-09 |