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

Model Number	LCS4K30BTOL
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	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lens cleaning sheath tip was about to come off the sheath.The issue was found during a procedure, which was completed with a replacement.There were no reports of patient harm.
Additional Manufacturer Narrative
The customer's allegation was confirmed.The device evaluation found the distal end post was misconfigured and the tip was rolled up and was about to come off.Based on the results of the investigation, it is likely that the customer pushed the scope in the sheath too far, causing the scope to make contact with the distal end post.The root cause has been determined to be that the instructions for use distributed in japan had inadequate warnings or caution about the risk of damaging the stopper when excessive force is used during insertion and the risk of not inspecting the sheath prior to use, which is an important step to ensure the tip of sheath is not damaged during insertion of a rigid scope.A device history review revealed no issues that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INSTACLEAR SHEATH, OLYMPUS 30° 4K ULTRA SCOPE, BOTTOM POSITION
• Common Device Name: FLEXIBLE FIBREOPTIC NASOPHARYNGOSCOPE
• 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: 19934211
• Report Number: 1037007-2024-00004
• Device Sequence Number: 2847096
• 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
• Report Date (Section B): 08/07/2024

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: LCS4K30BTOL
• Device Lot Number: AV179741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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