MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL 8/120MM PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	IAS8-120LP
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event ¿sound cap had come out and was inside the patient¿s abdomen¿ was confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 23 reports, regarding 23 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: if using the optional sound cap (8mm, 12mm): inspect sound cap foam and seal prior to use; use caution when inserting a sharp or large device through the blue sound caps seal; and inspect the sound cap after use of physical damage of any kind.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the ias8-120lp, airseal 8/120mm port was being used on (b)(6) 2023 during a ventral hernia procedure and ¿i had an incident where the valve on the airseal sound cap had come out and was inside the patient¿s abdomen.The physician¿s assistant believes it came out while they were passing mesh for a ventral hernia.They were able to remove it and the patient was fine, but stated if they had not seen it, they could have left it in the patient.¿.There was no injury or impact to the patient or user.After further assessment it was found that the cap was removed with a surgical grasper.The procedure was completed without a delay.¿patient is fine.¿ there was no medical/surgical intervention required for the patient/user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: AIRSEAL 8/120MM PORT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 16843173
• Report Number: 3007305485-2023-00098
• Device Sequence Number: 17857782
• Product Code: GCJ
• UDI-Device Identifier: 10845854045701
• UDI-Public: (01)10845854045701(17)251127(10)202211284
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2025
• Device Model Number: IAS8-120LP
• Device Catalogue Number: IAS8-120LP
• Device Lot Number: 202211284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic