MAUDE Adverse Event Report: GYRUS ACMI, INC. LENS CLEANER TUBESET STANDARD 5/PK

Model Number	LCTS100S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the white plastic that sticks into the normal saline bag of the subject device was broken from the time of unpacking.The event occurred out of the box failure for a therapeutic procedure and it was completed with an olympus back-up device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection, and the reported failure was confirmed.Based on the results of the investigation a root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: component failure of the introduction needle.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.

• Brand Name: LENS CLEANER TUBESET STANDARD 5/PK
• Common Device Name: LENS CLEANER TUBESET STANDARD 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: 21367620
• Report Number: 1037007-2025-00003
• Device Sequence Number: 12891474
• Product Code: EOB
• UDI-Device Identifier: 00821925040052
• UDI-Public: 00821925040052
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: LCTS100S
• Device Lot Number: G24A05111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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