MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL 5/100MM PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	IAS5-100LP
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
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 for trends through the complaint system to assure patient safety.Device not yet received.
Event or Problem Description
The distributor reported on behalf of the customer that the ias5-100lp, airseal 5/100mm port was being used on (b)(6) 2023 and ¿the thread of the 5mm airseal trocar broke off when being pulled out of the patient and had to be removed by the surgeon.¿.There was no injury or impact to the patient or user.The procedure was completed with a 5 minute delay.An alternate device ias-100lpi was used.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The distributor reported on behalf of the customer that the ias5-100lp, airseal 5/100mm port was being used on (b)(6) 2023 and ¿the thread of the 5mm airseal trocar broke off when being pulled out of the patient and had to be removed by the surgeon.¿.There was no injury or impact to the patient or user.The procedure was completed with a 5 minute delay.An alternate device ias-100lpi was used.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not being returned and the photographic evidence provided does not appear to verify the complaint; 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.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 57 reports, regarding 60 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 the following: 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 5/100MM 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 16706786
• Report Number: 3007305485-2023-00077
• Device Sequence Number: 5670278
• Product Code: GCJ
• UDI-Device Identifier: 10845854045626
• UDI-Public: (01)10845854045626(17)250829(10)202208305
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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: 08/29/2025
• Device Model Number: IAS5-100LP
• Device Catalogue Number: IAS5-100LP
• Device Lot Number: 202208305
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic