MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-20 for EVIS EXERA SIGMOIDOVIDEOSCOPE CF-Q160S manufactured by Olympus Medical System Corp..
[4335080]
Olympus was informed that during a flexible sigmoidoscopy procedure, the patient complained they felt a burning sensation during the procedure and the patient stated they could feel the heat coming from the lamp even prior to the scope being inserted into the anus. When the scope was removed, the physician noted that the tip of the scope was hot.
Patient Sequence No: 1, Text Type: D, B5
[11599716]
The device has not yet been returned to olympus for evaluation. The exact cause of the user's experience could not be conclusively determined at this time. If additional information becomes available at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00125 |
| MDR Report Key | 3720566 |
| Report Source | 05,06 |
| Date Received | 2014-03-20 |
| Date of Report | 2014-02-28 |
| Date of Event | 2014-02-28 |
| Date Mfgr Received | 2014-02-28 |
| Date Added to Maude | 2014-04-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEM CORP. |
| Manufacturer Street | 2951 ISHIKAWA-CHO HACHIOJI-SHI |
| Manufacturer City | TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS EXERA SIGMOIDOVIDEOSCOPE |
| Generic Name | SIGMOIDOVIDEOSCOPE |
| Product Code | FAM |
| Date Received | 2014-03-20 |
| Model Number | CF-Q160S |
| Catalog Number | CF-Q160S |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEM CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-20 |