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

Model Number	LCS4K30BTOL
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported two black stains of about 0.5 mm were found on the inner paper.The issue was found before opening the sterilized pack.The device was replaced and the procedure (an unspecified procedure) was completed using a similar device.There was no patient harm, no injury reported due to the event.
Additional Manufacturer Narrative
Address: full name of the establishment is (b)(6) hospital.The subject device was evaluated at service business center (sbc).Device evaluation has confirmed the reported issue.Visual inspection was performed, two spots of dirt or foreign matter were found in the sterilization pack of the device.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
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, the root cause has been determined to be environmental debris got sealed into the packaging during the packaging process.Per the pictures provided, these particles of debris are within the specification that is allowed with this device.Olympus will continue to monitor field performance for this device.

• Brand Name: INSTACLEAR SHEATH, OLYMPUS 30° 4K ULTRA SCOPE, BOTTOM POSITION
• Common Device Name: INSTACELAR SHEATH LENS CLEANER
• 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: 17296072
• Report Number: 1037007-2023-00019
• Device Sequence Number: 6095903
• Product Code: EOB
• UDI-Device Identifier: 00821925041417
• UDI-Public: (01)00821925041417(17)270929(10)AV191743
• 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,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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: AV191473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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