MAUDE Adverse Event Report: GYRUS ACMI, INC LENS CLEANER SHEATH,4MM X 180MM,SCOPE WITH UNIVERSAL POSITION LIGHT CABLE 5/PK; ENDOSCOPE LENS CLEANER, GAS/FLUID, SINGLE-USE

Model Number	LCS1800UNST
Medical Device Problem Codes	Contamination (1120); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when customer took out the product, " black things" described as "like a lump of powder found " in the sterility pack.The device was replaced with similar device.The issue found during preparation for use for a therapeutic otorhinolaryngology surgery.The intended procedure was completed with similar device.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
Olympus japan service business center (sbc) noted that as a result of the inspection, it was noted that the inside of the sterilization pack visually / under a microscope in an unopened state, multiple black foreign substances of 0.5 mm were found on the top (opened part), and brown foreign substances with a length of about 1 mm were found on the bottom.Photos of the device were provided.The subject device is being shipped on the way to the legal manufacturer for investigation.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
The subject device was received and evaluated.The device arrived in the original device packaging with no signs of tears or openings.The device returned un-used, the part number and lot were verified.The "contamination" was reviewed and it is noted as debris from the wooden spool that the white netting is receiving wrapped around.The netting comes to the facility on a huge wooden spool, sometimes, debris from the spool is trapped in the white netting and is not recognized by production personnel.The device was returned, upon evaluation the device was still sealed in the original product packaging, unopened.Visual inspection confirmed the debris inside the sterile barrier.There were no other abnormalities noted in the visual inspection, customer phenomenon confirmed.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.This product with lot av105330 was manufactured within all specifications.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause has been determined to be the third party packaging and transport of raw material (white netting) used in the manufacturing of lcs1800unst.The netting is received in on a big wooden spool, this spool can collect debris from transportation to processing the raw material in for usage and even, transportation from the warehouse to the manufacturing floor.The white netting used to encapsulate the lens cleaner before being placed in the seal pouch, sometimes contains microscopic debris which is not easily seen to the naked eye.This debris, is intertwined in the netting and is not dislodged from the netting until disrupted by vigorous movement (transportation, packing and or shaking the device package) and etc.The products are quality checked using sampling of the lot.This particular device from the lot av105330 ((b)(4)) manufactured could have not been selected in the random sampling, thus letting this particular device make it through sterilization operations and customer distribution.Even though debris was in the sterile packaging, the device was still sterile and the debris had only adhered to the sealed packaging and not the device.Olympus will continue to monitor complaints for this device.

• Brand Name: LENS CLEANER SHEATH,4MM X 180MM,SCOPE WITH UNIVERSAL POSITION LIGHT CABLE 5/PK
• Common Device Name: ENDOSCOPE LENS CLEANER, GAS/FLUID, SINGLE-USE
• Manufacturer (Section D): GYRUS ACMI, INC; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: todd brill ; 2925 appling rd; bartlett, TN 38133 ; 5082077661
• MDR Report Key: 15142045
• Report Number: 1037007-2022-00013
• Device Sequence Number: 5615087
• Product Code: EOB
• UDI-Device Identifier: 00821925040069
• UDI-Public: 00821925040069
• 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
• Report Date (Section B): 10/16/2022

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: LCS1800UNST
• Device Lot Number: AV105330
• 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: 07/04/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 10/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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