MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. BASIC LAP PACK; LAPAROSCOPY KIT

Model Number	89-10501
Medical Device Problem Codes	Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on 11/20/2023 hole in back table cover.The actual sample has not been returned to deroyal for evaluation at this time.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
Hole in back table cover.
Additional Manufacturer Narrative
A complaint was received on 11/20/2023 hole in back table cover.The sample has been returned to deroyal for evaluation.The root cause was determined to be from the placement of the yankauer within the tray.Corrective action: quality control specialist contacted tray engineering to evaluate the tray for a placement change on the yankauer within the tray.Engineering change order number 60184 has been created for a placement change for the yankauer.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: BASIC LAP PACK
• Common Device Name: LAPAROSCOPY KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 18310070
• Report Number: 3005011024-2023-00037
• Device Sequence Number: 12416045
• Product Code: FDE
• UDI-Device Identifier: 00749756363105
• UDI-Public: 00749756363105
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: ENFDISC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2023

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: 89-10501
• Device Lot Number: 59838625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (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