MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL 8/100MM PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	IAS8-100LP
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
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
A sales representative reported on behalf of a customer that the ias8-100lp, airseal 8/100mm port device was being used during an unnamed procedure on approximately (b)(6) 2024, and ¿two of the trocars from the same box both had issues with the sound cap tearing (one of them fell off entirely).¿ follow-up assessment confirmed that in ¿the second event the rubbery lining of the cap tore off and was discarded.¿ additionally, the device was ¿in use on surgical site however unable to determine if direct contact¿ with the patient; however, the event reportedly occurred ¿outside of the patient¿ and ¿fragments were retrieved from sterile field not patient cavity¿.There was no injury, medical/surgical intervention or extended hospitalization required for the patient after the sound cap tore and fell off.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A sales representative reported on behalf of a customer that the ias8-100lp, airseal 8/100mm port device was being used during an unnamed procedure on approximately on (b)(6) 2024, and ¿two of the trocars from the same box both had issues with the sound cap tearing (one of them fell off entirely).¿.Follow-up assessment confirmed that in ¿the second event the rubbery lining of the cap tore off and was discarded.¿.Additionally, the device was ¿in use on surgical site however unable to determine if direct contact¿ with the patient; however, the event reportedly occurred ¿outside of the patient¿ and ¿fragments were retrieved from sterile field not patient cavity¿.There was no injury, medical/surgical intervention or extended hospitalization required for the patient after the sound cap tore and fell off.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event ¿sound cap tearing¿ was confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.Root cause cannot be determined, however, based upon provided photos; a possible cause of this event could be using sharp or large device through the cannula.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 third such occurrence 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 46 reports, regarding 57 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 0.00004.Per the instructions for use, the user is advised: if using the optional sound cap (8 mm, 12 mm): inspect sound cap foam and seal prior to use.Inspect the sound cap after use for physical damage of any kind.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: AIRSEAL 8/100MM 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 19527220
• Report Number: 3007305485-2024-00085
• Device Sequence Number: 7560474
• Product Code: GCJ
• UDI-Device Identifier: 10845854045718
• UDI-Public: (01)10845854045718(17)270404(10)202404044
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/08/2024

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: IAS8-100LP
• Device Lot Number: 202404044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic