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

Catalog Number	IASB12-100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A sales representative reported on behalf of a customer that the iasb12-100, 12 mm access port and obturator with blunt tip,100 mm length device was used in a procedure on (b)(6)2025, and ¿iasb12-100 was being utilized in a robotic surgery with davinci port ¿double cannulated¿ inside of it.Staff noticed port was cracked at the distal end of hassan port, and blue plastic piece was shattered as well.Pieces of port broke off into the patient.According to staff xray was done to find pieces that fell into patient, but staff was uncertain whether they retrieved all pieces out of the patient.When speaking to dr.On (b)(6) who was not the operating surgeon but was present in the room, he said he didn¿t notice anything out of the ordinary.Other staff who were present were not around to give their account, so i will follow up with more information as it becomes available to me.¿.The procedure was completed.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.No further information has been provided to date.This report is being raised due to the reported injury of possible retained foreign bodies in the patient.
Event or Problem Description
A sales representative reported on behalf of a customer that the iasb12-100, 12 mm access port and obturator with blunt tip, 100 mm length device was used in a procedure on (b)(6) 2025, and "iasb12-100 was being utilized in a robotic surgery with davinci port 'double cannulated' inside of it.Staff noticed port was cracked at the distal end of hassan port, and blue plastic piece was shattered as well.Pieces of port broke off into the patient.According to staff xray was done to find pieces that fell into patient, but staff was uncertain whether they retrieved all pieces out of the patient.When speaking to dr.[¿] on (b)(6), who was not the operating surgeon but was present in the room, he said he didn't notice anything out of the ordinary.Other staff who were present were not around to give their account, so i will follow up with more information as it becomes available to me".The procedure was completed.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.No further information has been provided to date.This report is being raised due to the reported injury of possible retained foreign bodies in the patient.
Additional Manufacturer Narrative
Examination of returned used device iasb12-100 found that the tip of the port had cracked and part of the cracked portion was hanging out of place but still connected.The blue plastic covering the port had shattered into multiple pieces, three were found completely disconnected from the device and a fourth was stuck to the device right below its intended place.A root cause cannot be determined; however, based upon the photos, device evaluation, risk assessment and ifu, a possible cause of this event could be the use of excessive force.(b)(4).Per the instructions for use, the user is advised to take care that the outer wall of the airseal access port is only in contact with tissue and is neither trapped between nor collides with hard surfaces, such as other instruments or bone.Prolonged or sudden contact with hard surfaces can result in damage to or breakage of the access port.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.Do not use excessive downward force.We will continue to monitor per regulatory requirements to help ensure patient safety.
Additional Manufacturer Narrative
Update: the device lot number has been received; blocks d.4, g.3, and h.4 have been updated accordingly.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 one device for this lot number and failure mode.Examination of returned used device iasb12-100 found that the tip of the port had cracked and part of the cracked portion was hanging out of place but still connected.The blue plastic covering the port had shattered into multiple pieces, three were found completely disconnected from the device and a fourth was stuck to the device right below its intended place.A root cause cannot be determined; however, based upon the photos, device evaluation, risk assessment and ifu, a possible cause of this event could be the use of excessive force.(b)(4).We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the iasb12-100, 12 mm access port and obturator with blunt tip,100 mm length device was used in a procedure on (b)(6) 2025, and ¿iasb12-100 was being utilized in a robotic surgery with davinci port ¿double cannulated¿ inside of it.Staff noticed port was cracked at the distal end of hassan port, and blue plastic piece was shattered as well.Pieces of port broke off into the patient.According to staff xray was done to find pieces that fell into patient, but staff was uncertain whether they retrieved all pieces out of the patient.When speaking to dr.[¿] on (6) 2025 who was not the operating surgeon but was present in the room, he said he didn¿t notice anything out of the ordinary.Other staff who were present were not around to give their account, so i will follow up with more information as it becomes available to me.¿.The procedure was completed.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.No further information has been provided to date.This report is being raised due to the reported injury of possible retained foreign bodies in the patient.

• Brand Name: AIRSEAL
• Common Device Name: GCJ - 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 22529418
• Report Number: 3007305485-2025-00112
• Device Sequence Number: 7932547
• Product Code: GCJ
• UDI-Device Identifier: 10845854045602
• UDI-Public: (01)10845854045602(17)280317(10)202503184
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: IASB12-100
• Device Lot Number: 202503184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 08/11/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 07/31/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic