MAUDE Adverse Event Report: TECAN SCHWEIZ AG FREEDOM EVO 200; STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Model Number 10641200

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  malfunction  

Event Description

Laboratory reported that the front panel of an evo 200 instrument fell and hit the operator on the head.Additionally the operator was splashed with the liquid she was loading into the instrument.The liquid was aqueous, non-hazardous buffers.No injuries occured.No medical attention was needed.

Manufacturer Narrative

An initial report is being filed in an abundance of caution as there is the potential for injury if it were to recur.The laboratory confirmed there were no injuries requiring medical attention.More information will be provided in the follow-up report once the material has been returned to manufacturer and the investigation is completed.

Manufacturer Narrative

The suspected parts (gas springs) were returned to the manufacturer for review and testing.Upon review and testing it was determined the incorrect gas spring was installed during maintenance.A 50n (newton) gas spring was installed during maintenance where a 75n spring should have been.This information is clearly provided in the service instructions.The returned springs were tested and it was confirmed that the door would not hold with the incorrect springs used.A tecan field service engineer replaced the gas springs with the correct 75n part.The incident did not lead to death or serious deterioration in the health of a patient or used.The laboratory confirmed there were no injuries requiring medical attention.The service procedures address spring replacement on standard instrument configurations including standard cut outs.The instrument involved in this incident has a non-standard (customized) front panel which is not covered as part of the standard service procedures.The fse did not recognize that the front panel was non-standard with a partial cut-out and executed the gas spring replacement according to the service documentation for a standard instrument with a standard cut-out in the front panel which resulted in the selection of the wrong gas springs.The current service procedures do not address non-standard door configurations.Update service manual and checklist to verify correct gas springs selected for specific front panel configuration e.G.Customized or non-standard configurations is needed.Additionally field service team was notified via csi_2022-04 as a mitigation to remind all fse's so that the error could not be repeated.Sap database was checked for other possible impacted instruments and none were found.

Event Description

Laboratory reported that the front panel of an evo 200 instrument fell and hit the operator on the head.Additionally the operator was splashed with the liquid that was being loaded into the instrument.The liquid was aqueous, non-hazardous buffers.No injuries occured.No medical attention was needed.

• Brand Name: FREEDOM EVO 200
• Type of Device: STATION, PIPETTING AND DILUTING, FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ AG; seestrasse 103; maennedorf, zurich 8708 ; SZ 8708
• Manufacturer (Section G): TECAN SCHWEIZ AG; seestrasse 103; maennedorf, zurich 8708 ; SZ 8708
• Manufacturer Contact: jillian walker ; seestrasse 103; zurich 8708 ; SZ 8708
• MDR Report Key: 12465913
• MDR Text Key: 283147950
• Report Number: 3003402518-2021-00001
• 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,Followup
• Report Date: 02/25/2022

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: 10641200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2009
• 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