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

Model Number 28-0101B

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2019

Event Type  malfunction  

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 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
• Type of Device: ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 9491961
• MDR Text Key: 209778120
• Report Number: 1060680-2019-00012
• Device Sequence Number: 1
• Product Code: OCT
• UDI-Device Identifier: 00749756301749
• UDI-Public: 00749756301749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28-0101B
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1