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

Model Number LCTS100S

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned (ot).The physical evaluation confirmed that the inside of the sterilization pack had a stain and was yellowed.No stains are seen on the outside of the sterilization pack, and there are stains on the inside, so it is highly probable that the stains were not due to the outside getting wet, but were generated from the time of manufacture.No other defects were noted.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

During preparation for use, the box of the lens cleaner tubeset /5pack was opened and the sterilization packaging was dirty (yellowing).The issue was only observed on one package and not for other bundled products.A device from the same lot was used.No patient involvement was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer for medical device report# 1037007-2021-00004.As part of the investigation, olympus followed up with the user facility to obtain additional information.The user facility further reported the event was first observed during pre-use inspection.The procedure was completed using another device.There was a delay in the procedure to replace the device.There was no adverse outcome to the patient and or procedure and the sterile packaging of the device was not compromised.The device was returned but the outer box/original box was not.The subject device was returned to the legal manufacturer (osta).The evaluation found the device was still sealed in the original packaging.A visual inspection confirmed that no stains were on the outside of the sterilization pack, there were stains on the inside.There were no other abnormalities noted in the inspection.It is highly probable that the stains were not due to the outside getting wet but were generated from the time of manufacture.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found the investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause could not be determined.Olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer's updated investigation and to update the following sections: d8, g3, g6, h2, h4, h6 and h10.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the physical evaluation, it is highly probable that the stains were not due to the outside getting wet but were generated from the time of manufacture.There were no other abnormalities noted in the inspection.Further testing was conducted by the legal manufacturer to determine if the stains were generated during production.Cyclohexanone is used to bond the tubset fittings during production and was thought to have potentially caused the yellowing inside the pouch.However during a simulated accelrated life test, the cyclohexanone did not yellow after several weeks.Due to inconclusive evidence, olympus cannot definitively indentify the root cause of the reported failure.

• Brand Name: LENS CLEANER TUBESET STANDARD 5/PK
• Type of Device: LENS CLEANER
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11117297
• MDR Text Key: 225091925
• Report Number: 1037007-2021-00004
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 00821925040052
• UDI-Public: 00821925040052
• Combination Product (y/n): N
• PMA/PMN Number: K152531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LCTS100S
• Device Lot Number: AV879919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1