MAUDE Adverse Event Report: TECAN SCHWEIZ AG FREEDOM EVO-2 200; PIPETTING STATION FOR CLINICAL USE

Catalog Number 10641202

Device Problems Device Maintenance Issue (1379); Inadequate Service (1564)

Patient Problems Bone Fracture(s) (1870); Fracture, Arm (2351)

Event Date 03/10/2015

Event Type  Injury  

Event Description

A laboratory employee was injured when the adjustable front panel door on the instrument fell from an open position.The operator sustained a fracture to elbow and required medical attention at an urgent care facility.The laboratory reported that the front panel was falling very easily from an open position and had fallen several times before on employee's shoulders and head; however, there had been no injuries.This was the first report to tecan of the problem.

• Brand Name: FREEDOM EVO-2 200
• Type of Device: PIPETTING STATION FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ AG; maennedorf, zuerich ; SZ
• MDR Report Key: 4660168
• MDR Text Key: 5623142
• Report Number: 1037985-2015-00001
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10641202
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2015
• Distributor Facility Aware Date: 03/10/2015
• Device Age: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 03/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention