MAUDE Adverse Event Report: ALLEN MEDICAL SYSTEMS, INC. YELLOFIN ELITE; STIRRUPS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2014

Event Type  malfunction  

Event Description

The patient's legs were being positioned and as the surgical technician adjusted the yellofin stirrup, it broke.There was no patient injury.The patient weighed 110 pounds and her leg was caught before it hit the operating floor.This has occurred on 3 separate occasions.

• Brand Name: YELLOFIN ELITE
• Type of Device: STIRRUPS
• Manufacturer (Section D): ALLEN MEDICAL SYSTEMS, INC.; 1 post office square; acton MA 01720
• MDR Report Key: 3590695
• MDR Text Key: 16082546
• Report Number: 3590695
• Device Sequence Number: 1
• Product Code: EYD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 01/15/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 50