MAUDE Adverse Event Report: TECAN SCHWEIZ AG FREEDOM EVO 150; STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Model Number 10641441

Device Problem Device Fell (4014)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

An initial report is being filed in an abundance of caution as there is the potential for more serious injury if it were to recur.The operator had been using the instrument all morning and did not experience issues with the front panel.The customer had said that the pin on the lower hinge had come out the field service engineer checked the instrument on the customer site, the pin appeared tight and in place.The fse could not reproduce the incident.There have been no other reports of the holding hinge screws or screws of the pin holding the gas spring being loose or falling out without manual manipulation.The evo operating manual is clear that the operator must open the front panel completely, operator training is also required to ensure appropriate instrument handling and use, the maintenance schedule was checked and had been done within the appropriate timeframe.It is unclear as to the root cause of why the door did not keep its open position and closed without manual influence.It is possible that the unsecured pin contributed to the incident however this is not confirmed.There is the potential that the operator did not open the front panel completely however this is not confirmed.This is an isolated incident and reports of this nature have not occurred in the past.As a preventive measure the hinges and gas springs were replaced and the instrument was returned to normal use.

Event Description

Laboratory reported that the front panel of an evo 150 instrument did not keep its open position and due to this it closed without manual influence.The front panel hit the operator in the face.Lab reported operator received first aid for a scratch and was evaluated by doctor as "ok".No medical attention was needed, no stitches were needed.

• Brand Name: FREEDOM EVO 150
• Type of Device: STATION, PIPETTING AND DILUTING, FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ AG; seestrasse 103; maennedorf, 8708 ; SZ 8708
• Manufacturer (Section G): TECAN SCHWEIZ AG; seestrasse 103; maennedorf, 8708 ; SZ 8708
• Manufacturer Contact: jillian walker ; seestrasse 103; maennedorf, zurich 8708 ; SZ 8708
• MDR Report Key: 14873916
• MDR Text Key: 295316501
• Report Number: 3003402518-2022-00001
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10641441
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1