MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL 12/120MM LPI PORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	IAS12-120LPI
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer ias12-120lpi, airseal 12/120mm lpi port was being used during a robotic radical prostatectomy w/ pelvic lymph node dissection procedure on (b)(6) 2023 when it was reported ¿pa was inserting a clip applier through a 12 airseal port with the sound cap on.The clip applier chipped some of the sound cap portion off and broke inside the cavity.The doctor and team were able to retrieve.It was also reported the device was retrieved using "grasper used by doctor on the robot to pick up the blue piece.¿ the procedure was completed with an alternate same device and reported ¿a few minutes delay.¿ the current status of the patient was reported as ¿fine.¿ there was no report of injury medical intervention, or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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.H3 other text : device not yet returned.
Additional Manufacturer Narrative
Reported event ¿sound cap portions off and broke inside the cavity¿ was confirmed.Received one ia12-120lpi in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the complaint was confirmed.The sound cap was broken.Root cause cannot be determined, however, based upon evaluation of the device and review of drawing, a possible cause of this event could be that sound cap is a thin piece of foam that can be easily damage while inserting devices.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.(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; use caution when inserting a sharp or large device through the blue sound cap seal; 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.
Event or Problem Description
The sales representative reported on behalf of the customer ias12-120lpi, airseal 12/120mm lpi port was being used during a robotic radical prostatectomy w/ pelvic lymph node dissection procedure on (b)(6) 2023 when it was reported ¿pa was inserting a clip applier through a 12 airseal port with the sound cap on.The clip applier chipped some of the sound cap portion off and broke inside the cavity.The doctor and team were able to retrieve.It was also reported the device was retrieved using "grasper used by doctor on the robot to pick up the blue piece.¿ the procedure was completed with an alternate same device and reported ¿a few minutes delay.¿ the current status of the patient was reported as ¿fine.¿ there was no report of injury medical intervention, or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: AIRSEAL 12/120MM LPI 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: 16794152
• Report Number: 3007305485-2023-00089
• Device Sequence Number: 15335300
• Product Code: GCJ
• UDI-Device Identifier: 10845854045688
• UDI-Public: (01)10845854045688(17)251213(10)202212145
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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 Expiration Date: 12/13/2025
• Device Model Number: IAS12-120LPI
• Device Catalogue Number: IAS12-120LPI
• Device Lot Number: 202212145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic