MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	IAS12-100LPI
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The distributor reported on behalf of the customer that the device, ias12-100lpi, 12 mm access port, was being used on (b)(6) 2024 during a robotic assisted lobectomy procedure and ¿part of the blue valve in the top valve fell into the surgical site.This was observed and removed.May have ended up with a fragment not observed.As i understand this fragment was ripped off during insertion of instrument, most probably endo gia".There was no impact or injury for the patient.The procedure was completed with ¿another connection¿ and a 5 minute delay.This report is being raised due to the reported injury of possible device fragmentation left in the patient.
Additional Manufacturer Narrative
The device will not be returned for evaluation, but photographic evidence has been provided.A root cause cannot be determined, however, based upon the photos and the adverse review board meeting, the likely root cause of the failure is due to misuse, including the use of sharp objects and excessive force.Usage warning information is communicated through the ifu.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 40 reports, regarding (b)(4), for this device family and failure mode.(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.Inspect the sound cap after use for physical damage of any kind.(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 object into the cannula.Only surgical hand instruments should be passed down the airseal access port.Do not insert trocars or robotic instruments down the airseal access port.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Update: per assessment received on 31oct24 "a fragment may have ended up in the abdominal cavity.The reason for this is if there were several pieces not only on piece it might well end up in the abdominal cavity since it is very difficult to observe such happening in surgery if your eye is not directed to the accident.All people who have the experience in surgery knows how difficult it is to observe a foreign object inside the human body.¿.The distributor reported on behalf of the customer that the device, ias12-100lpi, 12 mm access port, was being used on (b)(6) 2024 during a robotic assisted lobectomy procedure and ¿part of the blue valve in the top valve fell into the surgical site.This was observed and removed.May have ended up with a fragment not observed.As i understand this fragment was ripped off during insertion of instrument, most probably endo gia".There was no impact or injury for the patient.The procedure was completed with ¿another connection¿ and a 5 minute delay.This report is being raised due to the reported injury of possible device fragmentation left in the patient.

• 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: 20384484
• Report Number: 3007305485-2024-00151
• Device Sequence Number: 15455760
• Product Code: GCJ
• UDI-Device Identifier: 10845854045640
• UDI-Public: (01)10845854045640(17)270107(10)2024010811
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: IAS12-100LPI
• Device Lot Number: 2024010811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENDO GIA; ENDO GIA
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic