MAUDE Adverse Event Report: GYRUS ACMI, INC. INSTACLEAR SHEATH, OLYMPUS 30° 4K ULTRA SCOPE, BOTTOM POSITION

Model Number	LCS4K30BTOL
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 full name (initial reporter establishment name) - (b)(6) medical center.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 during an endoscopic sinus surgery (ess) procedure, the stopper at the tip of the instaclear sheath broke and fell into the patient's nasal cavity.The broken fragment was retrieved using forceps.After the retrieval, a visual check confirmed no residual fragments remained.The procedure was then completed using a replacement of the same device.There were no further reports of patient harm.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's approved final investigation.Updated fields: d8, d9, h2, h3, h6, h11.The device was returned to olympus for inspection and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: the tip of the sheath was deformed, and it was found that a component had come loose.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction caused by a component failure of the sheath tip.The correct assembly method is to stop when the scope hits the stopper at the tip of the sheath.However, it's possible that the stopper was damaged and missing because the scope was forced in.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: INSTACLEAR SHEATH, OLYMPUS 30° 4K ULTRA SCOPE, BOTTOM POSITION
• Common Device Name: INSTACLEAR SHEATH, OLYMPUS 30° 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: 24053917
• Report Number: 1037007-2026-00004
• Device Sequence Number: 9465747
• Product Code: EOB
• UDI-Device Identifier: 00821925041486
• UDI-Public: 00821925041486
• 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,Followup
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LCS4K30BTOL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/26/2026
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown