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

Model Number 89-10501

Device Problems Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2023

Event Type  malfunction  

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 Description

Hole in back table cover.

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
• Type of Device: 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
• MDR Text Key: 330277896
• Report Number: 3005011024-2023-00037
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFDISC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1