MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL 12/120MM LPI PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	IAS12-120LPI
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer, that the ias12-120lpi, airseal 12/120mm lpi port was being used during a robotic prostatectomy procedure on (b)(6) 2023 date when it was reported ¿during a robotic prostatectomy, surgeons and staff were also harvesting multiple lymph nodes, placing them into robo-8 anchor specimen bag.Specimen bag became stuck inside the 12mm airseal access port.The scrub assistant used a fair amount of force to try and removed the specimen and bag.The 12 mm airseal port cracked, a small blue plastic piece and inner clear cannula became dislodged from the airseal port.Blue plastic piece was retrieved, an x-ray was done to confirm there were no other pieces inside.¿ the procedure was completed without the use of an alternate device.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
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 for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Received one ias12-120lpi in opened original package.Lot number was not verified.Performed a visual inspection, the complaint was confirmed.The trocar was dissembled.While a root cause could not be specifically identified, based on the photos, a likely cause for the failure was the application of excessive force during use as robots are not supposed to be used with the trocar.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 (b)(4), regarding (b)(4), for this device family and failure mode.During this same time frame (b)(4) 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.Ensure that the patient is properly positioned so that organs are away from the penetration site.Direct the airseal access port¿s tip away from significant vessels and organs- do not use excessive downward force.Once partial entry has been accomplished, very little force is required to complete entry.Excessive force may cause injury to underlying anatomic structures.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 the ias12-120lpi, airseal 12/120mm lpi port was being used during a robotic prostatectomy procedure on (b)(6) 2023 date when it was reported ¿during a robotic prostatectomy, surgeons and staff were also harvesting multiple lymph nodes, placing them into robo-8 anchor specimen bag.Specimen bag became stuck inside the 12mm airseal access port.The scrub assistant used a fair amount of force to try and removed the specimen and bag.The 12 mm airseal port cracked, a small blue plastic piece and inner clear cannula became dislodged from the airseal port.Blue plastic piece was retrieved, an x-ray was done to confirm there were no other pieces inside.¿.The procedure was completed without the use of an alternate device.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer, that the ias12-120lpi, airseal 12/120mm lpi port was being used during a robotic prostatectomy procedure on (b)(6) 2023.Date when it was reported ¿during a robotic prostatectomy, surgeons and staff were also harvesting multiple lymph nodes, placing them into robo-8 anchor specimen bag.Specimen bag became stuck inside the 12mm airseal access port.The scrub assistant used a fair amount of force to try and removed the specimen and bag.The 12 mm airseal port cracked, a small blue plastic piece and inner clear cannula became dislodged from the airseal port.Blue plastic piece was retrieved, an x-ray was done to confirm there were no other pieces inside.¿ the procedure was completed without the use of an alternate device.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of the trocar breaking off is confirmed.The device has not been returned to date, but photographic evidence has been provided.While a root cause could not be specifically identified, based on the photos, a likely cause for the failure was the application of excessive force during use as robots are not supposed to be used with the trocar.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 128 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 use extreme caution during airseal access port insertion.Improper use of this product can result in life-threatening injury to internal organs and vessels.Ensure that the patient is properly positioned so that organs are away from the penetration site.Direct the airseal access port¿s tip away from significant vessels and organs- do not use excessive downward force.Once partial entry has been accomplished, very little force is required to complete entry.Excessive force may cause injury to underlying anatomic structures.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: AIRSEAL 12/120MM LPI PORT
• 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: 17832455
• Report Number: 3007305485-2023-00209
• Device Sequence Number: 3278681
• Product Code: GCJ
• UDI-Device Identifier: 10845854045688
• UDI-Public: (01)10845854045688(17)251212(10)202212135
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K190303
• 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,Followup
• Report Date (Section B): 12/13/2023

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 Expiration Date: 12/12/2025
• Device Catalogue Number: IAS12-120LPI
• Device Lot Number: 202212135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 11/14/2023; 11/17/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/15/2023; 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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: Male
• Patient Ethnicity: Non Hispanic