MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-26 for * UP-5600MDU/S manufactured by Sony Electronics Inc., Medical Systems Division.
[3695097]
During the surgical procedure, some anatomical pictures were taken with the laparoscopic camera. The images on the monitors were clear but once they were printed, they appeared to be extremely over exposed. Bio medical was called multiple times prior to them answering the page. Once they answered, they came to the room and no resolution was given to the problem. Bio medical said that they would have to come at the end of the procedure to inspect the printer/camera tower. Once the procedure was completed, bio med was called once again and they returned to the room. After inspecting, no reasoning was provided as to what caused the images to be clear on the monitor screens and to appear extremely over exposed on the printed pictures. The captured images were not able to be printed clearly and therefore, the surgeon was not able to put those images into the patient's record.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3203946 |
| MDR Report Key | 3203946 |
| Date Received | 2013-06-26 |
| Date of Report | 2013-06-26 |
| Date of Event | 2013-06-25 |
| Report Date | 2013-06-26 |
| Date Reported to FDA | 2013-06-26 |
| Date Reported to Mfgr | 2013-07-03 |
| Date Added to Maude | 2013-07-03 |
| 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 | 3 |
| 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 | * |
| Generic Name | CAMERA, SURGICAL AND ACCESSORIES |
| Product Code | LMC |
| Date Received | 2013-06-26 |
| Model Number | UP-5600MDU/S |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SONY ELECTRONICS INC., MEDICAL SYSTEMS DIVISION |
| Manufacturer Address | 1 SONY DRIVE PARK RIDGE NJ 07656 US 07656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-26 |