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)
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 for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer, that ias12-100lpi, 12 mm access port & palm grip obt w/bladeless optical tip was being used on an unknown date during a robot assisted prostatectomy procedure when it was reported ¿towards the end of the operation, the surgeon discovers that there are small pieces of plastic lying freely in the abdomen.The pieces are picked up with a laparoscopic forceps and when all ports are removed, they see that pieces are missing from the airseal port.They patch the pieces together to see that nothing is missing and comes to the conclusion that all the pieces are there and nothing is left in the patient.".The procedure was completed without the use of an alternate device.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned for evaluation, but photographic evidence has been provided.A root cause cannot be determined, however, based upon the photos, the likely root cause of the failure is due to misuse, including the use of sharp objects and 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 (b)(4) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) 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 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.
Event or Problem Description
The sales representative reported on behalf of the customer, that ias12-100lpi, 12 mm access port & palm grip obt w/bladeless optical tip was being used on an unknown date during a robot assisted prostatectomy procedure when it was reported ¿towards the end of the operation, the surgeon discovers that there are small pieces of plastic lying freely in the abdomen.The pieces are picked up with a laparoscopic forceps and when all ports are removed, they see that pieces are missing from the airseal port.They patch the pieces together to see that nothing is missing and comes to the conclusion that all the pieces are there and nothing is left in the patient." the procedure was completed without the use of an alternate device.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of 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: 20565576
• Report Number: 3007305485-2024-00161
• Device Sequence Number: 18111110
• Product Code: GCJ
• UDI-Device Identifier: 10845854045640
• UDI-Public: (01)10845854045640(17)270528(10)2024052810
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 2024052810
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic