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	08/25/2025
Type of Reportable Event	Malfunction
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 per regulatory requirements to help ensure patient safety.H3 other text: device not yet received.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report: mw5175447 on 2oct2025.The current complaint database has been researched for this event and there were no findings.The report was found to be written against ias8-120lp, 8 mm access port & low-profile obturator, device.It was stated that the device was being used during a robotic hysterectomy procedure on (b)(6) 2025.The report stated, ¿placed the airseal in the patient and was working for approximately 10 mins when they noticed the rubber seal from the trocar.Dr.(b)(6) removed the rubber seal.There was no patient harm and trocar never lost pneumo so case could proceed.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported as having been completed as planned without any delay.Further assessment confirmed that the fragment had fallen into the patient and was retrieved using a grasper.The patient¿s current status was reported as ¿fine¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of returned used ias8-120lp device found that there was a rubber seal returned with the access port.Note that an extension tube was also returned.Root cause cannot be determined, however, based upon ifu; a possible cause of this event could be that the sound cap was not removed before inserting a large object into 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 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 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.Using sterile technique, remove the airseal access port and optional sound cap (8 mm, 12 mm) from the package.To avoid damage, do not flip the device onto the sterile field.If desired, optional sound cap (8 mm, 12 mm) may be placed on cannula at this time.(note: if using optional sound cap, use caution when inserting a sharp or large device through the cannula.The optional sound cap may be removed from the cannula at any time during the procedure and should be removed before inserting any sharp or large objects into the cannula.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report mw5175447 on 2oct25.The current complaint database has been researched for this event and there were no findings.The report was found to be written against ias8-120lp, 8 mm access port & low profile obturator, device.It was stated that the device was being used during a robotic hysterectomy procedure on (b)(6) 2025.The report stated, "placed the airseal in the patient and was working for approximately 10 minutes when they noticed the rubber seal from the trocar.Dr.(b)(6) removed the rubber seal.There was no patient harm and trocar never lost pneumo so case could proceed." there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported as having been completed as planned without any delay.Further assessment confirmed that the fragment had fallen into the patient and was retrieved using a grasper.The patient¿s current status was reported as "fine¿.This report is being raised due to the reported 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 23265058
• Report Number: 3007305485-2025-00167
• Device Sequence Number: 18680718
• Product Code: GCJ
• UDI-Device Identifier: 10845854045701
• UDI-Public: (01)10845854045701(17)280629(10)202506304
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 202506304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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
• Patient Race: White