MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-16 for GOOSENECK CAMERA HOLDER ARM 8120-01 manufactured by Vision Systems Group, A Division Of Viking Systems Inc..
[21347987]
The camera holder has a tension screw that is loosened prior to cleaning and sterilization between uses. The returned product was returned disassembled and when inspected, was found to be missing one washer in the assembly. W/o this washer, device was reassembled and functioned according to specification.
Patient Sequence No: 1, Text Type: N, H10
[21429088]
During a surgical procedure, the camera holder became disassembled during positioning. The holder consists of 29 hollow cylinders called ball joints through which a multi-strand cable runs. The holder came apart causing the hollow cylinders to come loose. The pt was x-rayed to ensure no pieces were lodged in the pt. Hospital confirmed no pieces were seen on x-ray. No reported pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1223925-2010-00001 |
| MDR Report Key | 1848968 |
| Report Source | 05 |
| Date Received | 2010-09-16 |
| Date of Report | 2010-09-16 |
| Date of Event | 2010-08-26 |
| Date Mfgr Received | 2010-08-26 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2011-01-20 |
| 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 Street | 134 FLANDERS ROAD |
| Manufacturer City | WESTBOROUGH MA 01581 |
| Manufacturer Country | US |
| Manufacturer Postal | 01581 |
| Manufacturer Phone | 5083663668 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOOSENECK CAMERA HOLDER ARM |
| Generic Name | CAMERA HOLDER |
| Product Code | FXR |
| Date Received | 2010-09-16 |
| Returned To Mfg | 2010-08-31 |
| Model Number | 8120-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS INC. |
| Manufacturer Address | 134 FLANDERS ROAD WESTBOROUGH MA 01581 US 01581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-16 |