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

Catalog Number	IAS8-120LP
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A sales representative reported on behalf of a customer that the ias8-120lp, 8 mm access port & low-profile obturator device was used in a robotic hysterectomy procedure on (b)(6) 2025, and ¿blue foam became loose during case.No other issues occurred.Replaced the sound cap.No problems with case or patient.Just wanted to report soundcap did not work properly¿.The procedure was completed without the use of an alternate device and a delay of one minute.Further assessment found "the blue foam in the sound cap detached and became loose, also two out of the four slits on top detached into the surgical site.They were quickly and easily retrieved from the surgical site with a laparoscopic grasper." there was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the ias8-120lp, 8 mm access port & low profile obturator device was used in a robotic hysterectomy procedure on (b)(6) 2025, and ¿blue foam became loose during case.No other issues occurred.Replaced the sound cap.No problems with case or patient.Just wanted to report soundcap did not work properly¿.The procedure was completed without the use of an alternate device and a delay of one minute.Further assessment found "the blue foam in the sound cap detached and became loose, also two out of the four slits on top detached into the surgical site.They were quickly and easily retrieved from the surgical site with a laparoscopic grasper.".There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.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 (1) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 64 reports, regarding 81 devices, for this device family and failure mode.(b)(4).Per the instructions for use, the user is advised that 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 per regulatory requirements to help ensure patient safety.

• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 21561726
• Report Number: 3007305485-2025-00042
• Device Sequence Number: 17237068
• Product Code: GCJ
• UDI-Device Identifier: 10845854045701
• UDI-Public: (01)10845854045701(17)271021(10)202410214
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: IAS8-120LP
• Device Lot Number: 202410214
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic