MAUDE Adverse Event Report: TECAN SCHWEIZ AG FREEDOM EVO-2 200; PIPETTING STATON 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, ther had been no injuries.This was the first report to tecan of the problem.

Manufacturer Narrative

Tecan received a complaint on (b)(4) 2015 indicating the gas spring that holds the front panel door in an open position and controls the descent was not working as expected.The door panel had fallen injuring an operator.A tecan field service engineer was dispatched and replaced 2 gas springs on the instrument.The gas springs were returned to manufacturer for investigation.The gas springs were greater than 6 years old and were no longer meeting original specification.The investigation concluded that the gas springs had exceeded expected lifetime.The instrument model involved is the worst case configuration (i.E.Heaviest front panel and added dust cover).A remedial action will be initiated to replace all gas strips on the evo 200 instruments older than 3 years with the worst case configuration.Additional corrective action to update tecan service directions to replace gas springs on all evo instruments on a 3 year cycle as part of routine preventive maintenance will be implemented.

• Brand Name: FREEDOM EVO-2 200
• Type of Device: PIPETTING STATON FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ AG; maennedorf zuerich ; SZ
• Manufacturer Contact: alexander kreig ; 103 seestrasse; maennedorf zuerich 8708 ; SZ 8708 ; 449228560
• MDR Report Key: 4660252
• MDR Text Key: 15315271
• Report Number: 3003402518-2015-00002
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• 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
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention