MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-24 for OLYMPUS CF-Q160L manufactured by Olympus.
[2244979]
During a routine screening colonoscopy, a small plastic ring (. 5cm in diameter) came off of the scope itself. It was identified in and retrieved from the colon, with no adverse effect on the patient. The scope, which had been last inspected that same day, was removed from service and sent for further inspection and repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021892 |
| MDR Report Key | 2226873 |
| Date Received | 2011-08-24 |
| Date of Report | 2011-08-24 |
| Date Added to Maude | 2011-09-02 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2011-08-24 |
| Returned To Mfg | 2011-08-22 |
| Model Number | CF-Q160L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-24 |