MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	IAS12-100LPI
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, ias12-100lpi, 12 mm access port & palm grip obt w/bladeless optical tip, was being used during a robotic diaphragmatic ligation procedure on (b)(6) 2025 when it was reported, ¿12mm x 100mm airseal access port, sound cap had one of the blue leaflets tear off in the case.¿ there was no report of medical intervention or hospitalization for the patient.Further assessment found that ¿the trocar was in use on the sterile field, one of the blue leaflets fell off during instrument insertion with a maryland.The blue leaflet fell into the patient- they were able to extract the leaflet as soon as it happened.The patient is okay.The nurse told me that during the procedure there were a lot of instrument exchanges through the airseal access port.¿.There was ¿not much of a delay¿ due to the incident.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, ias12-100lpi, 12 mm access port & palm grip obt w/bladeless optical tip, was being used during a robotic diaphragmatic ligation procedure on (b)(6) 2025 when it was reported, ¿12mm x 100mm airseal access port, sound cap had one of the blue leaflets tear off in the case.¿ there was no report of medical intervention or hospitalization for the patient.Further assessment found that ¿the trocar was in use on the sterile field, one of the blue leaflets fell off during instrument insertion with a maryland.The blue leaflet fell into the patient- they were able to extract the leaflet as soon as it happened.The patient is okay.The nurse told me that during the procedure there were a lot of instrument exchanges through the airseal access port.¿.There was ¿not much of a delay¿ due to the incident.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.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 30 complaints, regarding 36 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 that if using the optional sound cap (8 mm, 12 mm): inspect sound cap foam and seal prior to use.Inspect the sound cap after use for physical damage of any kind.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: AIRSEAL
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 21949504
• Report Number: 3007305485-2025-00082
• Device Sequence Number: 8382382
• Product Code: GCJ
• UDI-Device Identifier: 10845854045640
• UDI-Public: (01)10845854045640(17)271111(10)2024111110
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: IAS12-100LPI
• Device Lot Number: 2024111110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic