MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL; 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	07/18/2024
Type of Reportable Event	Malfunction
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 video assisted thoracic surgery on (b)(6) 2024 and ¿i was recently made aware of an incident on (b)(6) 2024 at (b)(6) hospital where a corner of the rubber valve on the sound cap of an airseal 12mm trocar ripped off and was found in the patient¿s abdomen.The circulation nurse reports that the rubber valve ripped after inserting and removing a stapler from the trocar.They also report they have been operating with the same stapler for a year and this has not happened before.I have recommended to the account that they should remove the sound cap before inserting the stapler or removing specimen¿¿.Per further assessment it was found that the fragment was retrieved and ¿the patient is fine, no harm done to the patient.¿.There was no extended stay at the hospital for the patient.The procedure was completed with a 5 minute delay.This report is being raised due to the reported 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.H3 other text : 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 during a video assisted thoracic surgery on (b)(6) 2024 and ¿i was recently made aware of an incident on (b)(6) 2024 at holy name hospital where a corner of the rubber valve on the sound cap of an airseal 12mm trocar ripped off and was found in the patient¿s abdomen.The circulation nurse reports that the rubber valve ripped after inserting and removing a stapler from the trocar.They also report they have been operating with the same stapler for a year and this has not happened before.I have recommended to the account that they should remove the sound cap before inserting the stapler or removing specimen¿¿.Per further assessment it was found that the fragment was retrieved and ¿the patient is fine, no harm done to the patient.¿.There was no extended stay at the hospital for the patient.The procedure was completed with a 5 minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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 (b)(4) reports, 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 the following: 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 for trends through the complaint system to assure patient safety.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 19892230
• Report Number: 3007305485-2024-00113
• Device Sequence Number: 7796832
• Product Code: GCJ
• UDI-Device Identifier: 10845854052006
• UDI-Public: (01)10845854052006(17)261025(10)202310264
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: IAS12-150LPI
• Device Lot Number: 202310264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic