MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-13 for 3600 BASE UNIT W/ VUCAPTURE manufactured by Vts Medical Systems.
[45923268]
A steris surgical specialist inspected the surgical monitor and found that one of two screws for the monitor power cord strain relief had loosened subsequently falling into the sterile field. The screw should have fallen into the monitor cable cover however, the monitor cable cover was loose allowing the screw to fall away from the cover. The reported event may be caused by user facility personnel moving the monitor via the cables causing strain. The steris surgical specialist advised personnel of the proper operation of moving/rotating the monitor. The operator manual states, "with both hands, grip the side bezel of the monitor and rotate clockwise or count clockwise to achieve the desired orientation. The monitor screen should be fully vertical or tilted forward toward the floor before rotation to ensure proper clearance of the suspension yoke arm. " the surgical specialist re-installed the screw, tightened the monitor cable cover and confirmed the unit to be operating properly. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[45923269]
The user facility reported that a screw from the surgical monitor fell into the sterile field. No report of injury. No procedural delays or cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000404456-2016-00004 |
| MDR Report Key | 5654178 |
| Date Received | 2016-05-13 |
| Date of Report | 2016-05-13 |
| Date of Event | 2016-04-13 |
| Date Mfgr Received | 2016-04-13 |
| Date Added to Maude | 2016-05-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | VTS MEDICAL SYSTEMS |
| Manufacturer Street | 40 MELVILLE PARK RD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 3600 BASE UNIT W/ VUCAPTURE |
| Generic Name | SURGICAL MONITOR |
| Product Code | KQM |
| Date Received | 2016-05-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VTS MEDICAL SYSTEMS |
| Manufacturer Address | 40 MELVILLE PARK RD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-13 |