MAUDE Adverse Event Report: GYRUS ACMI, INC INSTACLEAR SHEATH, OLYMPUS 0 DEGREE SCOPE, UNIV POSITION; ENDOSCOPE LENS CLEANER

Model Number	LCS1500UNOL
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when the sterilization pack was lifted , the contents suddenly fell out and found the sterile pack was not sealed on the side opposite of the opening.The issue occurred at preparation for use for a therapeutic nasal endoscopic surgery.The device was replaced.Intended procedure was completed using a similar device.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
The subject device was returned at olympus service business center (b)(4).Visual inspection noted that there were no seal marks on the bottom side of the sterilization pack which usually seen when the sterilization pack is opened.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, it is likely there was a manufacturing error.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
Additional Manufacturer Narrative
Correction to d4, udi number, from (b)(4) to (b)(4).

• Brand Name: INSTACLEAR SHEATH, OLYMPUS 0 DEGREE SCOPE, UNIV POSITION
• Common Device Name: ENDOSCOPE 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: 15812517
• Report Number: 1037007-2022-00022
• Device Sequence Number: 15207496
• 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,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2023

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: LCS1500UNOL
• Device Lot Number: AV171034
• 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: 10/23/2022
• Supplement Date Received by Manufacturer: 12/21/2022; 07/24/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 01/16/2023; 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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