MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-07 for OPSIS Z-CAM VS7100 * manufactured by V. Mueller Div. Baxther Healthcare Corp..
[22430]
Surgeons complained the camera was blurry and out of focus, and unable to see anatomy. Laparoscopic cholecystectomy converted to open procedure. Biomedical engineering tech evaluation of camera system found that the camera picture has too much chroma (purple). During the past year the camera has "hsd" problems with color changing and an inability to maintain color during surgery cases. The camera has also been fluctuating in light intensity, which has made it difficult to distinguish the color of tissue. The hosp owns 2 camera systems and both have a history of poor quality picture. Both have been returned to the mfr twice during the past year for various problems, the mfr has not found any problem with the color fluctuations with the cameras. The monitors have also been returned to the mfr for evaluation of color changes. Replaced a diode in each to improve the picture contrast.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009658 |
| MDR Report Key | 35041 |
| Date Received | 1996-08-07 |
| Date of Report | 1996-07-29 |
| Date of Event | 1996-07-11 |
| Date Added to Maude | 1996-08-09 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPSIS Z-CAM |
| Generic Name | SURGICAL CAMERA BOX |
| Product Code | FWC |
| Date Received | 1996-08-07 |
| Model Number | VS7100 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | BC#70974 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 36458 |
| Manufacturer | V. MUELLER DIV. BAXTHER HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-08-07 |