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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Conmed japan reported on behalf of a customer that the ias12-100lpi, 12 mm access port & palm grip obt w/bladeless optical tip device was being used during a robot-assisted prostatectomy procedure on (b)(6) 2024, and ¿the air seal trocar broke, and both the inner and outer layers of the double structure fell into the body.The surgeon said that it should not have broken unless some kind of excessive force had been applied, but he had no idea when it happened.He also reported that he had been having difficulty removing the anchor ii bag that had been used to retrieve tissue fragments and was unsure whether this incident occurred during this procedure or another procedure.The assistant doctor also said he didn't know because it was unclear whether the device had come into contact with the da vinci arm.¿.The procedure was completed without the use of an alternate device.Follow-up assessment confirmed that all fragments were removed from the patient.There was a delay of "about 20 min", and there was no injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.The anchor ii bag will be listed as a concomitant device; there are no allegations against it.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Received one ias12-100lpi in opened original packaging.Lot number was verified.Performed a visual inspection, the distal tip of the device is broken and the inside of the cannula is detached from the device.A root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be the use of excessive force.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.(b)(4).Per the instructions for use, the user is advised the following: take care that the outer wall of the airseal access port is only in contact with tissue and is neither trapped between nor collides with hard surfaces, such as other instruments or bone.Prolonged or sudden contact with hard surfaces can result in damage to or breakage of the access port.Do not use excessive downward force.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of a customer that the ias12-100lpi, 12 mm access port & palm grip obt w/bladeless optical tip device was being used during a robot-assisted prostatectomy procedure on (b)(6) 2024, and ¿the air seal trocar broke, and both the inner and outer layers of the double structure fell into the body.The surgeon said that it shoud not have broken unless some kind of exessive force had been applied, but he had no idea when it happened.He also reported that he had been having difficulty removing the anchor ii bag that had been used to retrieve tissue fragments and was unsure whether this incident occurred during this procedure or another procedure.The assistant doctor also said he didn't know because it was unclear whether the device had come into contact with the da vinci arm.¿ the procedure was completed without the use of an alternate device.Follow-up assessment confirmed that all fragments were removed from the patient.There was a delay of "about 20 min", and there was no injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.The anchor ii bag will be listed as a concomitant device; there are no allegations against it.

• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 20357968
• Report Number: 3007305485-2024-00148
• Device Sequence Number: 7283962
• Product Code: GCJ
• UDI-Device Identifier: 10845854045640
• UDI-Public: (01)10845854045640(17)261015(10)202310165
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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: IAS12-100LPI
• Device Lot Number: 202310165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANCHOR II BAG.; ANCHOR II BAG.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic