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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
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 sales representative reported on behalf of the customer that the ias12-150lpi, airseal 12/150mm lpi port was being used on (b)(6) 23 during a robotic partial nephrectomy and ¿the conmed/airseal rep was present during this case.The staff was using a clip applier instrument through the ias12-150lpi and noticed that one of the blue plastic flaps from the noise reduction cap had become dislodged from the white cap housing and was laying inside the abdominal cavity.This flap was retrieved with a grasper and removed from the patient.Surgeon dr.Said there was no injury to patient.The surgical assist who was handling the clip applier and putting it through the airseal port, said that perhaps the business end of the clip applier instrument had gotten caught on this blue plastic flap and perhaps dislodged it.He noticed a puncture hole/mark on the blue flap.¿.There was no injury or impact to the patient or user.There was no medical/surgical intervention required for the patient.The procedure was completed with an unknown alternate device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received two ias12-100lpi in opened original package.Lot number was able to be verified.Performed a visual inspection, the complaint was confirmed.The blue plastic flaps from the noise reduction cap were fragmented.Root cause cannot be determined, however, based upon evaluation of the device and review of drawing, a possible cause of this event could be that sound cap is a thin piece of foam that can be easily damage while inserting devices.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 21 reports, regarding 27 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: 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 ias12-150lpi, airseal 12/150mm lpi port was being used on (b)(6) 2023 during a robotic partial nephrectomy and ¿the conmed/airseal rep was present during this case.The staff was using a clip applier instrument through the ias12-150lpi and noticed that one of the blue plastic flaps from the noise reduction cap had become dislodged from the white cap housing and was laying inside the abdominal cavity.This flap was retrieved with a grasper and removed from the patient.Surgeon dr.Said there was no injury to patient.The surgical assist who was handling the clip applier and putting it through the airseal port, said that perhaps the business end of the clip applier instrument had gotten caught on this blue plastic flap and perhaps dislodged it.He noticed a puncture hole/mark on the blue flap.¿.There was no injury or impact to the patient or user.There was no medical/surgical intervention required for the patient.The procedure was completed with an unknown alternate device.This report is being raised due to the reported 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: 16877855
• Report Number: 3007305485-2023-00101
• Device Sequence Number: 12585498
• Product Code: GCJ
• UDI-Device Identifier: 10845854052006
• UDI-Public: (01)10845854052006(17)250817(10)202208185
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: 08/17/2025
• Device Model Number: IAS12-150LPi
• Device Catalogue Number: IAS12-150LPI
• Device Lot Number: 202208185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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