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

Model Number	89-10501
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Hole in pack prior to opening, suction punctured through outer packaging.
Additional Manufacturer Narrative
A user facility medwatch report (#4913020000-2023-8004) was received on 02/26/2024 reporting hole in pack prior to opening, suction punctured through outer packaging.The actual sample was not returned for evaluation and no lot number was provided.Root cause: possibly rough handling, during casing, or shipping from an unknown source.The following corrective actions have been taken by deroyal: this issue has been reviewed with the room supervisors due to no lot number being provided.Additional guidance was given to manufacturing to indicate that this product has had a report of hole in back table cover to increase scrutiny during the assembly and casing process.An inventory check of the tray was made by deroyal, a total of 8 trays of the 89-10501 lot 60124321 were inspected, and no discrepancies were identified during the inspection.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: 18954115
• Report Number: 3005011024-2024-00007
• Device Sequence Number: 7085205
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/21/2024
• 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