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

Catalog Number	IAS8-120LP
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
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.
Event or Problem Description
The customer reported that the ias8-120lp, airseal 8/120mm port, device was being used during a robotic urology case procedure on (b)(6) 2024 when it was reported ¿part of cap of airseal port broke off and ended up in patient.¿.Further assessment questioning found that the fragment was removed from the surgical site.The procedure was completed with the use of an alternate airseal port and a 30-minute delay.The current status of the patient was reported as ¿okay¿.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The customer reported that the ias8-120lp, airseal 8/120mm port, device was being used during a robotic urology case procedure on (b)(6) 2024 when it was reported ¿part of cap of airseal port broke off and ended up in patient.¿.Further assessment questioning found that the fragment was removed from the surgical site.The procedure was completed with the use of an alternate airseal port and a 30-minute delay.The current status of the patient was reported as ¿okay¿.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one ias8-120lp in opened original packaging.The lot number was verified.The sound cap was the only thing returned.Performed a visual inspection, the rubber seal was returned disassembled from the sound cap and torn in multiple pieces.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.A 2 year lot history review shows a total of 1 device for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised that to failure to properly follow the instructions for use can lead to serious surgical consequences.Only surgical hand instruments should be passed down the airseal access port.Do not insert trocars or robotic instruments down the airseal access port.Improper use can result in damage to or breakage of the access port.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.We will continue to monitor for trends through the complaint system to assure patient safety.

• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 19380314
• Report Number: 3007305485-2024-00080
• Device Sequence Number: 18068263
• Product Code: GCJ
• UDI-Device Identifier: 10845854045701
• UDI-Public: (01)10845854045701(17)270406(10)202404066
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: IAS8-120LP
• Device Lot Number: 202404066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic