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

Catalog Number	IAS8-100LP
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, ias8-100lp, 8 mm access port & low profile obt w/bladeless optical tip, was being used during a robot assisted lap myomectomy procedure on (b)(6) 2025 when it was reported, ¿manufacturer defect; item quality" and "one portion of inner plastic folding part broke off into surgical site.¿ there was no reported injury, medical intervention, or hospitalization for the patient.Further assessment requested found that the fragmentation fell into the surgical site and was removed with a robotic instrument.The fragmentation was not from a sound cap.It is unknown what caused the breakage as the fragmentation was only seen during the procedure within the cavity.The procedure was completed without any report of delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of returned used device ias8-100lp found that part of the seal from the sound cap had broken off.Root cause cannot be determined, however, based upon evaluation of the device, review of drawing, and the ifu; a possible cause of this event could be excessive downward force.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 24 complaints, regarding 24 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 to use extreme caution during airseal access port insertion.Improper use of this product can result in life-threatening injury to internal organs and vessels.Do not use excessive downward force.Once partial entry has been accomplished, very little force is required to complete entry.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, ias8-100lp, 8 mm access port & low profile obt w/bladeless optical tip, was being used during a robot assisted lap myomectomy procedure on (b)(6) 2025 when it was reported, ¿manufacturer defect; item quality" and "one portion of inner plastic folding part broke off into surgical site.¿.There was no reported injury, medical intervention, or hospitalization for the patient.Further assessment requested found that the fragmentation fell into the surgical site and was removed with a robotic instrument.The fragmentation was not from a sound cap.It is unknown what caused the breakage as the fragmentation was only seen during the procedure within the cavity.The procedure was completed without any report of delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: 21771958
• Report Number: 3007305485-2025-00062
• Device Sequence Number: 8087031
• Product Code: GCJ
• UDI-Device Identifier: 10845854045718
• UDI-Public: (01)10845854045718(17)271111(10)202411115
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: IAS8-100LP
• Device Lot Number: 202411115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic