MAUDE Adverse Event Report: GYRUS ACMI, INC. INSTACLEAR SHEATH, OLYMPUS 0 DEGREE SCOPE, UNIV POSITION; ENDOSCOPE LENS CLEANER, GAS/FLUID, SINGLE-USE

Model Number	LCS1500UNOL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The customer reported to olympus that while using the instaclear system (instaclear sheath, olympus 0 degree scope, univ position) during a therapeutic endoscopic nasal surgery, the protuberance at the tip of the lens cleaning sheath broke off.It fell into the patient¿s nose, but it was removed after being confirmed on endoscopic image.The user noted they do not know how to push the rigid endoscope.There were no allegations of patient effects.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it was determined that there was no manufacturing, material or processing related cause for this failure mode.The root cause of the reported event is due to excessive force by the user during insertion of the scope.If the user pushes pass where the scope is supposed to stop during insertion, the scope will have direct contact with the stopper.This direct contact with the stopper along with the applied force used to insert it, will damage the tip of the lens cleaner.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿use caution against trying to close the gap between the scope and the stopper at the end of the lens cleaner.¿.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction to field b1.

• Brand Name: INSTACLEAR SHEATH, OLYMPUS 0 DEGREE SCOPE, UNIV POSITION
• Common Device Name: ENDOSCOPE LENS CLEANER, GAS/FLUID, SINGLE-USE
• 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: 17294945
• Report Number: 1037007-2023-00018
• Device Sequence Number: 20585224
• Product Code: EOB
• UDI-Device Identifier: 00821925040137
• UDI-Public: 00821925040137
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2024

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: LCS1500UNOL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 07/27/2023; 07/01/2024
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/08/2023; 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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