MAUDE Adverse Event Report: GYRUS ACMI, INC LENS CLEANER TUBESET STANDARD 5/PK

Model Number	LCTS100S
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was received at olympus (b)(4) site.Initial evaluation of the returned subject device confirmed the reported issue.Inspection found foreign matter that seems to be human hair is mixed in the sterilization pack.Investigation is ongoing.This report will be supplemented accordingly following investigations.
Event or Problem Description
It was reported that during preparation for use for an endoscopic nasal sinus surgery procedure, the unopened sterile pack of lcts100s was found with a foreign matter that looked like a hair.The product was replaced with the same product model.The intended procedure was competed with no impact or harm to the patient.No user injury was reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.This product was manufactured in specification.An investigation was completed by the oem and determined that there was no manufacturing nor material processing related root cause for this failure mode.The root cause has been proposed to be either an improper handling of the raw materials before and or while complete assembly of the device.Foreign material/fiber material can we presented in raw materials while in storage bins, transportation from storage to usage location and assembly of the raw materials to complete the finished good in the clean room.It is likely that the foreign material was presented in the packaging of the device.The foreign material/fiber material could have been presented at any point within the assembly/packaging processes.These devices are visually inspected 100% before sealing and packaging.This is believed to be an isolated incident as this is the first report event description in the past twelve months.Olympus will continue to monitor the field performance of this device.

• Brand Name: LENS CLEANER TUBESET STANDARD 5/PK
• Common Device Name: LENS CLEANER TUBESET STANDARD 5/PK
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12140109
• Report Number: 1037007-2021-00047
• Device Sequence Number: 16384044
• Product Code: EOB
• UDI-Device Identifier: 00821925040052
• UDI-Public: 00821925040052
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: LCTS100S
• Device Lot Number: AV105224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1