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

Model Number	LCS4K30BTOL
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's allegation was confirmed.The device evaluation found the stopper welded to the tip had rolled up and was about to break.Based on the results of the investigation, it is likely that the following led to the malfunction: the root cause has been determined to be that a specific region's ifu did not warrant the caution of inserting the scope too far and not having a gap between the hub and light post would damage the distal end post.This in turn, caused the user to insert the scope in the sheath too far, avoiding the designated gap, and damaging the distal end post." 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.
Event or Problem Description
It was reported that the instaclear sheath tip of the sample sheath was fuzzy.The event occurred during the procedure.The procedure was completed with a similar device.There were no reports of patient harm.

• 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.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19937515
• Report Number: 1037007-2024-00007
• Device Sequence Number: 7433030
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

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: AV257282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2023
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS BORESCOPE
• Patient Sex: Unknown