MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEFOGGER; ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY

Model Number	28-0101B
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: due to the investigation findings and the absence of lot information, a root cause could not be determined.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary an internal complaint ((b)(4)) was received indicating the foam pad packaged with anti-fog solution (part 28-0101b) was peeling away and fell off of the backing.The customer reported this created a risk for an object to be retained in the patient.The customer did not provide a lot number for the affected product.Additionally, a sample was reported to be available, but as of the date of this report, that sample has not been returned.A photo of the defective item was provided via email and confirmed the reported incident.An inventory check was performed of the affected component (raw material 040-4001), and the reported issue could not be duplicated.No changes have been made to the manufacturing process.A review of quality documentation for the raw materials was performed and confirmed that all materials were within specification.No changes have occurred to the raw materials.From 2017 to present, deroyal has sold (b)(4) cases of finished good 28-010b.During that time frame, five complaints have been received for the foam pad not sticking and 1 complaint for the x-ray detectable strip falling off.This equates to a complaint-to-sales ratio of 0.01773 percent.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
Portions of the foam pad packaged with the anti-fog solution peeled away and feel off of the backing.This created the potential for a retained object in the patient.The nurse noticed part of the foam was missing and was able to locate the section that fell off in the field.

• Brand Name: DEFOGGER
• Common Device Name: ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• MDR Report Key: 9491961
• Report Number: 1060680-2019-00012
• Device Sequence Number: 11108719
• Product Code: OCT
• UDI-Device Identifier: 00749756301749
• UDI-Public: 00749756301749
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K982465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2019

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: Health Professional
• Device Model Number: 28-0101B
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1