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

Catalog Number	IAS5-120LP
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
Event or Problem Description
The sales representative reported on behalf of the customer that the ias5-120lp, 5 mm access port & low-profile device was being used during an unknown procedure on (b)(6) 2025 when it was reported ¿the outer canula of the trocar broke in half and a piece fell into the patient¿s abdomen.All of the pieces were retrieved from the patient with no injury.There was a 5-10 minute delay for retrieval.¿.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.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.
Additional Manufacturer Narrative
Reported event of ¿trocar broke in half and a piece fell into the patient's abdomen.¿ is confirmed.Examination of returned used device ias5-120lp found that the outer cannula had broken and was completely separated into two parts about halfway down the device.A root cause cannot be determined; however, based upon the event description, the evaluation, and the ifu, a possible cause of this event could be the device was subjected to excessive 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.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 65 complaints, regarding 65 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.Only surgical hand instruments should be passed down the airseal access port.Do not insert trocars or robotic instruments down the airseal access port.Improper use can result in damage to or breakage of the access port.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 ias5-120lp, 5 mm access port & low-profile device was being used during an unknown procedure on (b)(6) 2025 when it was reported ¿the outer canula of the trocar broke in half and a piece fell into the patient¿s abdomen.All of the pieces were retrieved from the patient with no injury.There was a 5-10 minute delay for retrieval.¿.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 21933476
• Report Number: 3007305485-2025-00078
• Device Sequence Number: 9031584
• Product Code: GCJ
• UDI-Device Identifier: 10845854045657
• UDI-Public: (01)10845854045657(17)271212(10)202412124
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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: IAS5-120LP
• Device Lot Number: 202412124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic