MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-26 for 1488 HD * manufactured by Stryker Endoscopy.
[2943290]
Two incidents with face plate coming off the camera. It has not affected the two patients--no patient harm. However, hospital is opening cameras now away from the sterile field so the face plates can be inspected before placing on the sterile field. The problem is when face plates come off a camera the sterile field could be compromised. Staff do not know why this is happening. The device has been returned to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2814220 |
| MDR Report Key | 2814220 |
| Date Received | 2012-10-26 |
| Date of Report | 2012-10-26 |
| Date of Event | 2012-10-16 |
| Report Date | 2012-10-26 |
| Date Reported to FDA | 2012-10-26 |
| Date Added to Maude | 2012-11-01 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1488 HD |
| Generic Name | CAMERA, ENDOSCOPIC |
| Product Code | FWC |
| Date Received | 2012-10-26 |
| Model Number | 1488 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-26 |