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

Catalog Number 10641202

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problems Injury (2348); Needle Stick/Puncture (2462)

Event Date 03/28/2014

Event Type  Injury  

Event Description

A laboratory employee was injured reaching into the freedom evo 200 instrument while instrument was running on (b)(6) 2014.The event was reported to tecan on (b)(6) 2014 with a request to re-engage the door locks.The employee received a puncture to his finger from the fixed tip dispensing needles on the liquid handling arm.The finger bled and employee was initially treated by a corporate nurse.An internal safety incident was filed.No add'l info regarding treatment or the seriousness of injury was shared with tecan.The instrument was processing pt samples at the time of the incident.The door locks were disabled on the instrument.

Manufacturer Narrative

A tecan fse was on site on (b)(4) 2014 at laboratory for an unrelated issue and was informed that a lab employee was injured by the evo 200 robot's liquid handling arm when reaching into the instrument during operation.The instrument operator's finger was punctured by the fixed tip dispensing needles on the liquid handling arm.The laboratory was running pt samples at the time of the incident potentially resulting in biohazard exposure to the wound area.The door locks on the instrument were disabled allowing for the operator to reach in without having to pause the instrument.The door locks had been previously disabled.Tecan's labeling warns against accessing the instrument while in operation and the door locks are designed to prohibit access without pausing the instrument.A tecan field service engineer was dispatched to reconnect the door locks and test instrument to ensure it passed all safety tests.

• Brand Name: EVO-2 200
• Type of Device: PIPETTING STATION FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ; maennedorf zuerich ; SZ
• Manufacturer Contact: 103 seestrasse; maennedorf zuerich 8708 ; 449228560
• MDR Report Key: 3866641
• MDR Text Key: 4589137
• Report Number: 3003402518-2014-00001
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• 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 Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2005
• 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