ALLEN MEDICAL SYSTEMS
Received Apr 7, 2009 · Event occurred May 8, 2008
Report 1221538-2009-00003 · MDR key 1359116
Device
Generic name
Yellofin Stirrup
Manufacturer
Allen Medical SystemsModel number
O-YFASICatalog number
O-YFASI
Product problems
- Unintended System Motion
Patient
NA
- Physical Entrapment
- Injury
- Disability
Narrative
Description of Event or Problem
IN 2009, ALLEN MEDICAL LEARNED OF A LAWSUIT FILED REGARDING A PREVIOUSLY UNREPORTED 2008 INCIDENT INVOLVING A NURSE FROM MEDICAL CENTER. THERE WAS NO PT INVOLVEMENT. ACCORDING TO THE LEGAL COMPLAINT, THE NURSE "LIFTED UPON THE STIRRUP TO REMOVE IT FROM THE OPERATING TABLE. AS SHE LIFTED THE STIRRUP OUT OF THE SLOT ON THE OPERATING TABLE, THE STIRRUP UNEXPECTEDLY AND WITHOUT WARNING ENGAGED CAUSING THE STIRRUP TO SNAP SHUT ON PLAINTIFF'S LEFT HAND." ACCORDING TO THE DOCUMENT, "SEVERE AND PERMANENT INJURIES" WERE SUSTAINED.
Additional Manufacturer Narrative
AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. CO HAS NOT RECEIVED PHOTOGRAPHS OF THE DEVICE WHICH MAY HELP US UNDERSTAND THE NATURE OF THE COMPLAINT. IN LEGAL DOCUMENTS, THE SERIAL NUMBER PROVIDED FOR THE PRODUCT WAS REPORTED INCORRECTLY. (THE DEVICE IS ASSOCIATED WITH A RAIL CLAMP PRODUCT AND NOT A STIRRUP.) DUE TO THE LACK OF INFO, NO CONCLUSIONS CAN BE MADE AT THIS TIME.