MAUDE Adverse Event Report: CONMED UTICA AIRSEAL 12/120MM LPI PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	IAS12-120LPI
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
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
A sales representative reported on behalf of a customer that the ias12-120lpi, airseal 12/120mm lpi port device was being used during a robotic assisted laparoscopic cystectomy procedure on 22apr24, and the ¿airseal trocar cap pieces fell inside the peritoneum/body cavity.They were able to retrieve the item out of the abdomen and did not cause patient harm.The surgeon believes it was a piece of the airseal cap and described it as a blue piece.¿.The procedure was completed without the use of an alternate device and no delay was reported.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A sales representative reported on behalf of a customer that the ias12-120lpi, airseal 12/120mm lpi port device was being used during a robotic assisted laparoscopic cystectomy procedure on (b)(6) 2024, and the ¿airseal trocar cap pieces fell inside the peritoneum/body cavity.They were able to retrieve the item out of the abdomen and did not cause patient harm.The surgeon believes it was a piece of the airseal cap and described it as a blue piece.¿.The procedure was completed without the use of an alternate device and no delay was reported.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one ias12-120lpi in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the blue rubber seal torn into multiple pieces and detached from the sound cap.A root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be excessive downward 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.This is the only such occurrence for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised: 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.Use extreme caution during airseal access port insertion.Improper use of this product can result in life-threatening injury to internal organs and vessels.Do not use excessive downward force.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.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): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 19250243
• Report Number: 1320894-2024-00120
• Device Sequence Number: 7351513
• Product Code: GCJ
• UDI-Device Identifier: 10845854045688
• UDI-Public: (01)10845854045688(17)270215(10)202402165
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: IAS12-120LPI
• Device Lot Number: 202402165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic