MAUDE Adverse Event Report: COOPERSURGICAL, INC. K-SYSTEMS; LAMINAR AIRFLOW HOOD

Model Number	6.131.812.121
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The workstation was installed on (b)(6) 2025.During installation test, the equipment functioned properly.On (b)(6), the customer contacted the distributor because the left work area stopped heating and that there was a burning smell.Upon inspection, two screws on two solid-state relays were loose, with one of them causing sparks and a burning smell, dangerously close to electrical wiring.Service team tightened the screws and unit is functioning properly.No harm or patient involvement.No additional information available.(b)(4).
Additional Manufacturer Narrative
Device was serviced in the field and will not be returned.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h4, h6, h11.Correction: d4.Distribution history: the complaint product was purchased from uab life instruments on 3/13/25 and sold on 7/23/25.Manufacturing record review: manufacturing record review not applicable to this product.Incoming inspection review: incoming inspection record review not applicable to this product.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Note: observed and corrected by the distributor's service team, therefore, the complaint is confirmed.Root cause: no definitive root cause could be reliably determined for this issue at this time, however, there's potential the screws were loosened in transit or as a result of repeated heating and cooling cycles.Coopersurgical will continue to monitor this complaint condition for trends.
Event or Problem Description
No additional information.

• Brand Name: K-SYSTEMS
• Common Device Name: LAMINAR AIRFLOW HOOD
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 1350
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 1350
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611-1350 ; 4752651582
• MDR Report Key: 23816252
• Report Number: 1216677-2025-00057
• Device Sequence Number: 10067042
• Product Code: PUB
• UDI-Device Identifier: 00888937023985
• UDI-Public: (01)00888937023985
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: Health Professional
• Device Model Number: 6.131.812.121
• Device Catalogue Number: 6.131.812.121
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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