MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for ADULT COLONOSCOPE manufactured by Olympus America, Inc..
[59594860]
During colonoscopy, cable on large wheel of scope broke. The scope was almost at the cecum, but not close enough to complete exam. Scope had to be switched to another scope causing the exam to be started all over again patient had to receive additional sedation and prolong procedure time. The adult colonoscope was returned to olympus for repair on or about 08/05/2016. The patient tolerated the additional procedure time and medications without issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065958 |
| MDR Report Key | 6092479 |
| Date Received | 2016-11-09 |
| Date of Report | 2016-11-03 |
| Date of Event | 2016-08-03 |
| Date Added to Maude | 2016-11-10 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT COLONOSCOPE |
| Generic Name | ADULT COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2016-11-09 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS AMERICA, INC. |
| Manufacturer Address | CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-09 |