MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CCASC LAPAROTOMY PACK; GENERAL SURGERY TRAY (KIT)

Model Number	89-10558
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received on 07/03/2025 reporting missing lap quantity of 4 instead of 5.The sample has not been returned to deroyal for evaluation at this time.A supplier corrective action request (scar) was issued to the lap supplier (b)(4).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
Missing lap quantity of 4 instead of 5.
Additional Manufacturer Narrative
A user facility medwatch report (4900240000-2025-8094) was received on 07/03/2025 reporting missing lap quantity of 4 instead of 5.The sample was not returned to deroyal for evaluation.A supplier corrective action request (scar) was issued to the lap supplier meixin medical.The root cause was determined by meixin medical: current counting method: the appearance and count of each bundle of lap sponges are visually inspected manually.Then the bundles are applied to the weight checking system to determine whether they are within the set weight range and ensure correct count through weight sorting.There was a deviation between the weight value displayed on the check weigher screen and the actual weight of the product, but the operator failed to thoroughly check the weight checking system before using and didn't modify it promptly.Thus, the miscounted bundle was not identified and sorted out.The appearance of the lap sponge bundle is not flat enough when taken out from the turnover bags, resulting in a deviation between the weight value displayed on the check weigher screen and the actual weight, and the miscount was not identified and sorted out.The following corrective and preventive actions have been taken by meixin medical: improve the pre-production inspection points for weight checking system and include the points in the sop.Train operators to conduct pre-production inspections according to the inspection points to reduce the risk of count misidentification.Products with uneven appearance found during inspection should be tidied before flowing into the weight conveyor line to prevent weight deviation caused by product shaking during flow and reduce the risk of count misidentification.Train lap sponge packaging workers to pay attention and smoothly place the products into the turnover bags, so as to prevent product un-flatness, and reduce weight fluctuations in subsequent processes.Notify the complaint to all personnel, enhancing their quality awareness.Deroyal root cause was determined to be: the operator did not follow the standard work instruction to pay inattention to details.The following corrective and preventive actions have been taken by deroyal: a corrective and preventive action report (capa bp20-25-05-004) related to missing components has been issued.Integrated the quality improvement program (qip) to address part handling and inventory tracking discrepancies.Employees responsible for the missing components reflect on the customer complaints were retrained during the corrective actions that were taken during the complaint investigations.Management has developed a process for bin counting.This process is designed to be used for pre-counting out small items which are to be placed into custom procedural trays during each building of 4 trays.Small bins are located on the manufacturing worktables and items are pre-counted from bags containing larger quantities for the building of trays being assembled.The quantity within each bin will be in multiples of the parts listed on the bill of material multiplied by the number of trays being assembled during each building of 4 trays.As the trays are pushed down the worktable, the bins are emptied by putting each component into the trays as required by the work order parts list.The assembler is then responsible for re-filling each bin as he or she moves to the front of the assembly line to begin the assembly process on the next set of trays.The decision for what items should be bin pulled has been left up to the team leader based on the size of the raw material components.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: CCASC LAPAROTOMY PACK
• Common Device Name: GENERAL SURGERY TRAY (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: 22467706
• Report Number: 3005011024-2025-00008
• Device Sequence Number: 4234461
• Product Code: LRO
• UDI-Device Identifier: 00749756364430
• UDI-Public: 00749756364430
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 89-10558
• Device Lot Number: 62288951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/18/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown