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

Catalog Number 30020020

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 while operating the freedom evo instrument.The door locks were disabled and the operator reached into the instrument during operation.The operator's finger was punctured and the operator did receive medical treatment.The extent of treatment or the seriousness of the injury was not shared with tecan.The instrument was being used for r&d purposes.The laboratory stated that the door locks has been disabled for a long time and he did not know who disabled them.The laboratory sent a copy of their internal safety report to tecan indicating the door locks were re-engaged and prohibiting intentionally disabling equipment guards.

• Brand Name: EVO-2 200 MCA
• Type of Device: PIPETTING STATION FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ; maennedorf, zuerich ; SZ
• MDR Report Key: 3783536
• MDR Text Key: 4379888
• Report Number: 1037985-2014-00002
• 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: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• 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: 04/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 30020020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2014
• Distributor Facility Aware Date: 03/28/2014
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 03/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other