MAUDE Adverse Event Report: GYRUS ACMI, INC. INSTACLEAR SHEATH, OLYMPUS 0° 4K ULTRA SCOPE, UNIV POSITION

Model Number	LCS4K00UNOL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the instaclear sheath metal tube/pin has detached from the sheath (sleeve).It was complete at the beginning of the procedure, but was missing/detached at the end of the procedure.The issue occurred during a therapeutic functional endoscopic sinus surgery (fess).There were no reports of patient harm or injury.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additional information: d8, d9, h3, h4, h6, h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, damage was confirmed.It is likely that the user pushed the scope too far on the sheath closing the gap and breaking the distal tip.The event can be detected/prevented by following the instructions for use which state: caution! do not force the sheath hub all the way to the light post as a gap between the sheath hub and light post should be seen.If a gap is not visible, damage to the distal end may occur.Olympus will continue to monitor field performance for this device.

• Brand Name: INSTACLEAR SHEATH, OLYMPUS 0° 4K ULTRA SCOPE, UNIV POSITION
• Common Device Name: INSTACLEAR SHEATH
• 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: 20369068
• Report Number: 1037007-2024-00009
• Device Sequence Number: 3796465
• Product Code: EOB
• UDI-Device Identifier: 00821925041462
• UDI-Public: 00821925041462
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: LCS4K00UNOL
• Device Lot Number: AV179739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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
• Patient Sex: Unknown