MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. GENERAL LAPAROSCOPIC PACK; LAPAROSCOPY KIT

Model Number	89-3940
Medical Device Problem Codes	Component Missing (2306); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There were only 9 gauze rf in the pack (supposed to be 10).
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received on 2/16/2024 reporting that there were only 9 gauze rf in the pack (supposed to be 10).The sample was returned for evaluation.A supplier corrective action request (scar) was issued to the gauze supplier covidien.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.
Additional Manufacturer Narrative
A user facility medwatch report (#(b)(4)) was received on 2/16/2024 reporting that there were only 9 gauze rf in the pack (supposed to be 10).The sample was returned for evaluation.A supplier corrective action request (scar) was issued to the gauze supplier covidien.The returned response stated, "based on the information provided in the event and photo, the most likely cause of the event could not be determined.Common sequences of events and contributing factors that can lead to this event are documented in the covidien risk management file, which include causes due to a manufacturing defect.While it is impossible to determine an exact root cause for this reported quantity discrepancy defect, it is possible that this defect occurred during the handling of the gauze product throughout the distribution channel where the product is outside of our control.A review of the device history record indicates the product was released meeting all medtronic quality release specifications at the time of manufacture.Further action was not required/taken, the event had foreseen risk and is included in a data monitoring plan.".The true root cause could not be determined, the supplier stated that potential root causes included manufacturing error or handling of the product outside of their control.Deroyal production records were reviewed, no issue was found.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.
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received on 2/16/2024 reporting that there were only 9 gauze rf in the pack (supposed to be 10).The sample was returned to deroyal for evaluation, however due to the fact that the sample was contaminated, the supplier opted to utilize a photograph for evaluation.A supplier corrective action request (scar) was issued to the gauze supplier covidien.The returned response stated, "based on the information provided in the event and photo, the most likely cause of the event could not be determined.Common sequences of events and contributing factors that can lead to this event are documented in the covidien risk management file, which includes causes due to a manufacturing defect.While it is impossible to determine an exact root cause for this reported quantity discrepancy defect, it is possible that this defect occurred during the handling of the gauze product throughout the distribution channel where the product is outside of our control.A review of the device history record indicates the product was released meeting all medtronic quality release specifications at the time of manufacture.Further action was not required/taken, the event had foreseen risk and is included in a data monitoring plan." the true root cause could not be determined, the supplier stated that potential root causes included manufacturing error or handling of the product outside of their control.Deroyal quality control specialist reviewed production records; no issues were found.Deroyal quality control specialist checked inventory on hand, item number 901431 lot 230111at, there were no stacks of gauze found with incorrect quantites.This investigation is complete at this time.No further information is available at this time.We will provide a follow-up report if additional information becomes available.

• Brand Name: GENERAL LAPAROSCOPIC 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: rose earl ; 200 debusk lane; powell, TN 37849 ; 8653621051
• MDR Report Key: 18904144
• Report Number: 3005011024-2024-00006
• Device Sequence Number: 7876686
• Product Code: FDE
• UDI-Device Identifier: 00749756571524
• UDI-Public: 00749756571524
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2024

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: 89-3940
• Device Lot Number: 60112881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 06/18/2024; 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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