MAUDE Adverse Event Report: TECAN SCHWEIZ AG FLUENT 780; STATION, PIPETTING AND DILUTING, FOR CLINICAL USE,

Model Number	30042021
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported fluent 780 front shield does not remain open and falls from an open position.The customer confirmed no injuries occurred.
Additional Manufacturer Narrative
An initial report is being filed in an abundance of caution.There is the potential for serious injury to instrument operator if the front panel falls and comes into contact with the operator.The customer confirmed for this event no injury occured.A tecan service representative was dispatched to the instrument location and replaced the gas springs.The instrument is fully operational.A follow-up mdr will be filed after additional investigation.Note: this report or other information submitted by tecan under 21cfr part 803, and any release by fda of that report or information, does not reflect a conclusion by tecan or fda that the report or information constitutes an admission that the device, tecan, or its employees caused or contributed to the reportable event.
Event or Problem Description
Customer reported fluent 780 front shield does not remain open and falls from an open position.The customer confirmed no injuries occurred.
Additional Manufacturer Narrative
Follow-up narrative: the instrument's front panel door is supported by two 100n gas springs to keep it in the open position.The two gas springs associated with this report were returned for investigation.One spring was confirmed to not meet specifications, while the other was functioning properly.It was determined that the two gas springs were installed in the incorrect orientation (upside down) possibly contributing to a reduced lifespan.Further internal evaluation revealed that the gas springs were of two different ages.One gas spring's age aligned with the instrument's initial production date, while the other was dated after instrument's original production date.According to the tecan instrument service manual, gas springs should be replaced in pairs every three years by authorized tecan service personnel.There is no service record of gas spring replacement since installation performed by tecan.The instrument was produced in 2022 and the springs were still within the 3 year preventive maintenance cycle.In response to the complaint, tecan replaced the gas springs and verified that the instrument was operating according to specifications.The instrument was returned to routine use.In an abundance of caution, additional instruments in the laboratory were evaluated for gas spring integrity and replaced as a precaution.No remedial action is planned as a result of this complaint as there is no evidence of a systemic part defect or incorrect service or production performed by tecan.The instrument production record and assembly instructions show that the instrument left tecan production with the springs installed in the correct orientation.The case will be monitored as part of routine complaint trending.Note: this report or other information submitted by tecan under 21cfr part 803, and any release by fda of that report or information, does not reflect a conclusion by tecan or fda that the report or information constitutes an admission that the device, tecan, or its employees caused or contributed to the reportable event.

• Brand Name: FLUENT 780
• Common Device Name: 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: 19928256
• Report Number: 3003402518-2024-00001
• Device Sequence Number: 8234523
• Product Code: JQW
• UDI-Device Identifier: 07640137481117
• UDI-Public: (01)07640137481117(11)221108
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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
• Operator of Device: Other
• Device Model Number: 30042021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown