MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-22 for SKYTRON 4-090-03-1 manufactured by Amatech.
[27690947]
During a surgical case, a patient's leg was in a levitator stirrup when the stirrup spring upwards. No injuries were reported. Staff held the stirrup in place and the surgery was able to be completed. The facility is returning the stirrup to skytron for further evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825014-2015-00044 |
| MDR Report Key | 5130881 |
| Date Received | 2015-09-22 |
| Date of Report | 2015-09-22 |
| Date of Event | 2015-09-02 |
| Date Facility Aware | 2015-09-02 |
| Report Date | 2015-09-22 |
| Date Reported to FDA | 2015-09-22 |
| Date Reported to Mfgr | 2015-09-23 |
| Date Added to Maude | 2015-10-06 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 5000 36TH ST., S.E. |
| Manufacturer City | GRAND RAPIDS MI 49512 |
| Manufacturer Country | US |
| Manufacturer Postal | 49512 |
| Manufacturer G1 | SKYTRON, DIV. THE KMW GROUP, INC. |
| Manufacturer Street | 5000 36TH ST., S.E. |
| Manufacturer City | GRAND RAPIDS MI 49512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SKYTRON |
| Generic Name | LEVITATOR STIRRUP |
| Product Code | EYD |
| Date Received | 2015-09-22 |
| Model Number | NA |
| Catalog Number | 4-090-03-1 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMATECH |
| Manufacturer Address | ACTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-22 |