MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL 12/120MM LPI PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	IAS12-120LPI
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that the ias12-120lpi, airseal 12/120mm lpi port was being used on (b)(6) 2024 and the ¿distal tip of airseal 12mm port broke¿.There was no report of impact or injury to the patient.Per further assessment it was found that the reporter is not sure how and where the piece broke off the trocar and "it was not found or retrieved".This report is being raised due to the reported injury of fragmentation, although not found in the patient, they cannot produce the piece and its location is unknown.
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 ias12-120lpi, airseal 12/120mm lpi port was being used on (b)(6) 2024 and the ¿distal tip of airseal 12mm port broke¿.There was no report of impact or injury to the patient.Per further assessment it was found that the reporter is not sure how and where the piece broke off the trocar and "it was not found or retrieved".This report is being raised due to the reported injury of fragmentation, although not found in the patient, they cannot produce the piece and its location is unknown.
Additional Manufacturer Narrative
Update: section d4 lot number was changed from unknown to confirmed as 2024010311.Manufacturer narrative: received one ias12-120lpi in opened original packaging.Performed a visual inspection, the distal tip is broken.The broken piece was not returned with the device.A likely cause for this issue may be due to the use of excessive force during insertion of the trocar into the surgical site.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.(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 adequate pneumoperitoneum or pneumorectum is established.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.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: AIRSEAL 12/120MM 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: 19359991
• Report Number: 3007305485-2024-00078
• Device Sequence Number: 12366030
• Product Code: GCJ
• UDI-Device Identifier: 10845854045640
• UDI-Public: (01)10845854045640(17)270102(10)2024010311
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: IAS12-120LPI
• Device Lot Number: 2024010311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic