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

Catalog Number IAS12-120LPI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 10/23/2023

Event Type  Injury  

Event Description

Conmed japan reported on behalf of the customer that ias12-120lpi, airseal 12/120mm lpi port device was being used during a robot-assisted nephrectomy procedure post operatively on (b)(6) 2023 when it was reported ¿subcutaneous emphysema occurred, although the causal relationship with the product is unknown.The patient was not required to undergo any additional treatment, and the patient was merely observed.The confirmed event was that gas leakage occurred during the surgery, and pneumoperitoneum could not be maintained.After replacing the trocar and tube, pneumoperitoneum was restarted.After the surgery, doctors noticed that she had developed subcutaneous emphysema.The presence or absence of product defects and the causal relationship are unknown.The facility believes that if there is a hole somewhere in the trocar, it could lead to subcutaneous emphysema from the abdominal wall, so the actual item needs to be inspected and reported.¿.There was no report of medical intervention, or extended hospitalization to the patient or user.The device asm-evac1, trilumen filtered tube set was also used in this procedure and will be listed as a concomitant device.This report is being raised on the reported injury due to the patient being diagnosed with subcutaneous emphysema.

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.

Manufacturer Narrative

Received one ias12-120lpi in opened original packaging.Lot number was verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects.Performed a functional inspection using the airseal i.F.S.(c8457), the device functioned as intended and was able to maintain pneumoperitoneum.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.(b)(4).Per the instructions for use, the user is advised that higher insufflation pressures (> 15 mm hg) of carbon dioxide insufflation can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumothorax, pneumo-scrotum, and urinary retention.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 adequate pneumoperitoneum or pneumo-rectum is established.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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

Conmed japan reported on behalf of the customer that ias12-120lpi, airseal 12/120mm lpi port device was being used during a robot-assisted nephrectomy procedure post operatively on (b)(6) 2023 when it was reported ¿subcutaneous emphysema occurred, although the causal relationship with the product is unknown.The patient was not required to undergo any additional treatment, and the patient was merely observed.The confirmed event was that gas leakage occurred during the surgery, and pneumoperitoneum could not be maintained.After replacing the trocar and tube, pneumoperitoneum was restarted.After the surgery, doctors noticed that she had developed subcutaneous emphysema.The presence or absence of product defects and the causal relationship are unknown.The facility believes that if there is a hole somewhere in the trocar, it could lead to subcutaneous emphysema from the abdominal wall, so the actual item needs to be inspected and reported.¿.There was no report of medical intervention, or extended hospitalization to the patient or user.The device asm-evac1, trilumen filtered tube set was also used in this procedure and will be listed as a concomitant device.This report is being raised on the reported injury due to the patient being diagnosed with subcutaneous emphysema.

• Brand Name: AIRSEAL 12/120MM LPI PORT
• Type of Device: 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: 18150514
• MDR Text Key: 328302507
• Report Number: 3007305485-2023-00240
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10845854045688
• UDI-Public: (01)10845854045688(17)250719(10)202207204
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAS12-120LPI
• Device Lot Number: 202207204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: ASM-EVAC1, TRILUMEN FILTERED TUBE SET; ASM-EVAC1, TRILUMEN FILTERED TUBE SET
• Patient Ethnicity: Non Hispanic