MAUDE Adverse Event Report: PRESERVATION SOLUTIONS, INC. CLEARIT ANTI-FOG KIT; ANTI FOG SOLUTION

Catalog Number	PS003
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Distribution company notified preservation solutions, inc.(psi, manufacturer) on january 18, 2019 of a complaint that included an allegation from an end user that the clearit anti-fog solution kit device was not functioning as intended.The device is to be used to help prevent the fogging of endoscope lens during procedures.The allegation was that the clearit anti-fog solution did not prevent the lens from fogging during procedure.Additional follow-up information from the distributor regarding the complaint on january 21, 2019 that included information that the alleged incident took place on (b)(6) 2018 that included a statement regarding the impact of the complaint as "patient safety issue noted".Psi requested additional information regarding this statement and further information was provided from the end user via the distributor that indicated if the anti-fog solution is ineffective, time is wasted clearing the lens of fog.This would result in repeated entry into the trachea and bronchus with the endoscope which could potentially cause trauma to the airway and prolong a procedure.As of (b)(6) 2019, psi is awaiting the return of unused product from the end user/distributor for evaluation.Product lot released (b)(6) 2018 with a total quantity of (b)(4) units.All inventory from this lot has shipped from manufacturer's facility as of (b)(4) 2019.No additional complaints received by manufacturer (psi) regarding this product and/or lot number as of february 21, 2019.No additional reports of ineffective use of the device received by the manufacturer (psi) regarding this product and/or lot number as of february 21, 2019.
Event or Problem Description
Distribution company notified preservation solutions, inc.(psi, manufacturer) on january 18, 2019 of a complaint that included an allegation from an end user that the clearit anti-fog solution kit device was not functioning as intended.The device is to be used to help prevent the fogging of endoscope lens during procedures.The allegation was that the clearit anti-fog solution did not prevent the lens from fogging during procedure.Additional follow-up information from the distributor regarding the complaint on january 21, 2019 that included information that the alleged incident took place on (b)(6) 2018 that included a statement regarding the impact of the complaint as "patient safety issue noted".Psi requested additional information regarding this statement and further information was provided from the end user via the distributor that indicated if the anti-fog solution is ineffective, time is wasted clearing the lens of fog.This would result in repeated entry into the trachea and bronchus with the endoscope which could potentially cause trauma to the airway and prolong a procedure.As of (b)(6) 2019, psi is awaiting the return of unused product from the end user/distributor for evaluation.

• Brand Name: CLEARIT ANTI-FOG KIT
• Common Device Name: ANTI FOG SOLUTION
• Manufacturer (Section D): PRESERVATION SOLUTIONS, INC.; 1099 proctor drive; elkhorn WI 53121
• MDR Report Key: 8367379
• Report Number: 1000221028-2019-00113
• Device Sequence Number: 1019400
• Product Code: OCT
• UDI-Device Identifier: 10810805000146
• UDI-Public: 10810805000146
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K022826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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: No Information
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: PS003
• Device Lot Number: PS119206
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1