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

Model Number	IAS12-150LPi
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the device ias12-150lpi airseal 12/150mm lpi port was being used (b)(6) 2023 and ¿the blue plastic fell off of the soundcap and into the patient's abdomen during the case.They stated that this was during a robotic case but cannot remember what instrument was used down the as port.They stated that they were able to retrieve the piece of plastic and that the patient was ok.¿ there was no report of injury or impact for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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.
Additional Manufacturer Narrative
Received one ias12-150lpi in opened original packaging.Lot number was verified.Performed a visual inspection, the blue seal from the sound cap is disassembled from the cap and torn in half.All pieces were returned.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 34 reports, regarding 38 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised the following: if using the optional sound cap (8 mm, 12 mm): inspect sound cap foam and seal prior to use.Use caution when inserting a sharp or large device through the blue sound cap seal.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.
Event or Problem Description
The sales representative reported on behalf of the customer that the device ias12-150lpi airseal 12/150mm lpi port was being used (b)(6) 2023 and ¿the blue plastic fell off of the soundcap and into the patients abdomen during the case.They stated that this was during a robotic case but cannot remember what instrument was used down the as port.They stated that they were able to retrieve the piece of plastic and that the patient was ok.¿ there was no report of injury or impact for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 16467048
• Report Number: 3007305485-2023-00044
• Device Sequence Number: 5064347
• Product Code: GCJ
• UDI-Device Identifier: 10845854052006
• UDI-Public: (01)10845854052006(17)250427(10)202204284
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190303
• 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): 04/11/2023

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: 04/27/2025
• Device Model Number: IAS12-150LPi
• Device Catalogue Number: IAS12-150LPI
• Device Lot Number: 202204284
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic