MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL 8/120MM PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	IAS8-120LP
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the ias8-120lp, airseal 8/120mm port, was used during a gyn procedure on (b)(6) 2022 when it was reported, ¿airseal 8 mm trocar sound cap flaps broke off and fell in the patient.The surgeon was unable to retrieve all of the flaps and 3 of the 4 flaps were left in the patient¿.The procedure was completed without an alternative device and there was no report of a delay to the case.Further assessment questioning found that no imaging was done to help locate the 3 missing device caps and the patients status was, ¿okay¿.This was reported for a life threatening injury, but there was no report of medical intervention or prolonged hospitalization for the patient.This report is being raised on the basis of injury due to fragmentation left in the body.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.A device history record review found no abnormalities that would contribute to this reported event.A two-year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 27 reports, regarding 31 devices, for this device family and failure mode.(b)(6) per the instructions for use, the user is advised the following: the user is advised that if using the optional sound cap (8 mm, 12 mm): inspect sound cap blue foam and blue seal prior to use.Use caution when inserting a sharp or large device through the cannula.Inspect the sound cap after use for physical damage of any kind.Use extreme caution during airseal access port insertion.Improper use of this product can result in life-threatening injury to internal organs and vessels.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the ias8-120lp, airseal 8/120mm port, was used during a gyn procedure on (b)(6) 2022 when it was reported, ¿airseal 8 mm trocar sound cap flaps broke off and fell in the patient.The surgeon was unable to retrieve all of the flaps and 3 of the 4 flaps were left in the patient.¿.The procedure was completed without an alternative device and there was no report of a delay to the case.Further assessment questioning found that no imaging was done to help locate the 3 missing device caps and the patients status was, ¿okay¿.This was reported for a life threatening injury, but there was no report of medical intervention or prolonged hospitalization for the patient.This report is being raised on the basis of injury due to fragmentation left in the body.

• Brand Name: AIRSEAL 8/120MM 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: aubrey nardozzi ; 11311 concept blvd; largo, FL 33773 ; 7273995288
• MDR Report Key: 16062952
• Report Number: 3007305485-2022-00191
• Device Sequence Number: 2019926
• Product Code: GCJ
• UDI-Device Identifier: 10845854045701
• UDI-Public: (01)10845854045701(17)251004(10)202210054
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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 Expiration Date: 10/04/2025
• Device Model Number: IAS8-120LP
• Device Catalogue Number: IAS8-120LP
• Device Lot Number: 202210054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic