MAUDE Adverse Event Report: SUPER BRUSH LLC TROCLEAN, 5-7MM & 7-12MM; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	28-1002
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "the sponge attached to the stick separated during use and had to be retrieved form the trocar/patient which caused a delay in the procedure." deroyal industries requested return of the sample, but it was stated that it could not be returned.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Event or Problem Description
A user facility reported, "the sponge attached to the stick separated during use and had to be retrieved form the trocar/patient which caused a delay in the procedure.".
Additional Manufacturer Narrative
A supplier corrective action request (scar) was issued to the supplier, superbrush llc.Deroyal investigated inventory and found that all were within specification.A complaint to sales ratio was calculated from june 2021 to august 2023 and found to be (b)(4).Root cause: because the sample was unable to be returned, the root cause of the complaint was unable to be determined.Corrective and preventive action: an update to labeling was made to clarify the sizes of trocars to be used with the small and large size brushes.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: TROCLEAN, 5-7MM & 7-12MM
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SUPER BRUSH LLC; 800 worcester street; springfield MA 01151
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19950690
• Report Number: 1060680-2023-00011
• Device Sequence Number: 8810810
• Product Code: GEA
• UDI-Device Identifier: 00749756912822
• UDI-Public: 00749756912822
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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
• Device Model Number: 28-1002
• Device Lot Number: 58329415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown