MAUDE Adverse Event Report: GYRUS ACMI, INC. INSTACLEAR SHEATH, OLYMPUS 45° 4K ULTRA SCOPE, BOTTOM POSITION

Model Number	LCS4K45BTOL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the reported failure was confirmed.Based on the results of the investigation, it is likely the following led to the malfunction caused due to component failure.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
It was reported that instaclear sheath had a protruding part is bent toward the tip.The event occurred during inspection for use.There were no reports of patient harm.

• Brand Name: INSTACLEAR SHEATH, OLYMPUS 45° 4K ULTRA SCOPE, BOTTOM POSITION
• Common Device Name: INSTACLEAR SHEATH, OLYMPUS 45° 4K ULTRA SCOPE, BOTTOM POSITION
• 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: 24423818
• Report Number: 1037007-2026-00011
• Device Sequence Number: 10570063
• Product Code: EOB
• UDI-Device Identifier: 00821925041509
• UDI-Public: 00821925041509
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

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: LCS4K45BTOL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown