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

Model Number	LCS4K45BTOL
Medical Device Problem Codes	Material Deformation (2976); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection the root cause could not be identified.Based on the results of the investigation, the most probable cause of the complaint could not be established.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 observed that during the device evaluation, the instaclear sheath had a post at the distal end that was bent upward, resulting in a sharp edge.There were no reports of patient involvement.

• 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: 24013876
• Report Number: 1037007-2026-00003
• Device Sequence Number: 18790320
• Product Code: EOB
• UDI-Device Identifier: 00821925041509
• UDI-Public: 00821925041509
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: Other
• Device Model Number: LCS4K45BTOL
• Device Lot Number: G24A01453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/08/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3011050570-01/02/2024-00
• Patient Sequence Number: 1
• Patient Sex: Unknown