MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL 12/150MM LPI PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	IAS12-150LPI
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
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
The sales representative reported on behalf of the customer that the ias12-150lpi, airseal 12/150mm lpi port, was being used during a gynecological robot procedure on (b)(6) 23 when it was reported, ¿the customer noticed that at the end of the gynecological robot procedure, a piece of the external double-walled cannula was missing.After searching inside the abdomen, they found the piece of plastic.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed as planned.All fragmentation was recovered from the patient per the reporter.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the ias12-150lpi, airseal 12/150mm lpi port, was being used during a gynecological robot procedure on (b)(6) 2023, when it was reported, ¿the customer noticed that at the end of the gynecological robot procedure, a piece of the external double-walled cannula was missing.After searching inside the abdomen, they found the piece of plastic.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed as planned.All fragmentation was recovered from the patient per the reporter.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of the returned used device, item ias12-150lpi found threaded cannula assembly airseal broken off at the tip.The broken piece was not returned for evaluation.Examination was performed per print.While a root cause could not be specifically identified, based upon the evaluation, and photos, a likely cause for the failure was the application of excessive force during use as robots are not supposed to be used with the trocar.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 123 complaints, regarding (b)(4) 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 to 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 12/150MM LPI 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 17583216
• Report Number: 3007305485-2023-00192
• Device Sequence Number: 14359136
• Product Code: GCJ
• UDI-Device Identifier: 10845854052006
• UDI-Public: (01)10845854052006(17)260214(10)202302154
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: 02/14/2026
• Device Catalogue Number: IAS12-150LPI
• Device Lot Number: 202302154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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