MAUDE Adverse Event Report: GYRUS ACMI, INC. DIEGO ELITE TUBESET, DECLOG, 5/PK

Model Number	TS101DC
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the diego elite tubeset declog had brown oily fluid on the valve to the balloon.The issue occurred during the device's setup ¿ inspection for use.There were no reports of patient involvement.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.The date of the event is unknown.A supplemental report twill be submitted when provided.
Event or Problem Description
No new information received by the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.The device was not returned to olympus for inspection.A root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction to a previously submitted report.This event was reported in error, and it would be unlikely to cause or contribute to a death or a serious injury if it were to recur.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: DIEGO ELITE TUBESET, DECLOG, 5/PK
• Common Device Name: DIEGO ELITE TUBESET, DECLOG, 5/PK
• Manufacturer (Section D): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer (Section G): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 24334948
• Report Number: 1037007-2026-00010
• Device Sequence Number: 17371878
• Product Code: GEI
• UDI-Device Identifier: 00821925038820
• UDI-Public: 00821925038820
• Combination Product (Y/N): N
• PMA/510(K) Number: K123429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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: TS101DC
• Device Lot Number: G2405097
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/18/2026; 03/31/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/02/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown