MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL 8/120MM PORT; INSUFFLATOR, LAPAROSCOPIC

Catalog Number IAS8-120LP

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

Additional product code; gcj.At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the conmed representative reported issues with the the ias8-120lp, airseal 8/120mm port, lot 202011284 that kettering health network/grandview medical center recently experienced on (b)(6) 2021.Information received indicates the issue occurred during a laparoscopic robotic assisted hiatal hernia procedure.It was reported that after inserting a ray-tec into the abdomen through the assist port (the airseal 8/120mm port), the staff was trying to remove it.It would not fit and was pushed back into the abdomen to be removed from another port site with the trocar.Upon re-inserting the ray-tec, a small flap could be seen inside the patient¿s abdomen.Medical staff saw it, removed it and confirmed it to be a piece of the sound cap flap from the airseal 8mm port.There was no impact or injury to the patient and the procedure was successfully completed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as although removed, the piece did fall into the patient.

Manufacturer Narrative

Investigation of the customer's complaint is inconclusive.The device in question, used in the procedure, is not available for evaluation by conmed.No photographic evidence has been provided.Therefore, the reported failure cannot be verified, and root cause cannot be identified.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted and found no other similar events reported for this lot number.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also, per the ifu, the user is advised that failure to properly follow the instructions for use can lead to serious surgical consequences.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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the conmed representative reported issues with the the ias8-120lp, airseal 8/120mm port, lot 202011284 that (b)(6) medical center recently experienced on (b)(6) 2021.Information received indicates the issue occurred during a laparoscopic robotic assisted hiatal hernia procedure.It was reported that after inserting a ray-tec into the abdomen through the assist port (the airseal 8/120mm port), the staff was trying to remove it.It would not fit and was pushed back into the abdomen to be removed from another port site with the trocar.Upon re-inserting the ray-tec, a small flap could be seen inside the patient¿s abdomen.Medical staff saw it, removed it and confirmed it to be a piece of the sound cap flap from the airseal 8mm port.There was no impact or injury to the patient and the procedure was successfully completed.Additional clarification received notes the port had been in use the entire case, roughly 2 hours.Laparoscopic graspers and raytec, suction had all been used in /around port.Nothing unusual noticed about the patient¿s anatomy or port prior to use.No other information is available.The additional clarification received does not impact the filing of this report.This incident will still this report is being raised on the basis of malfunction with potential for injury upon reoccurrence as although removed, the piece did fall into the patient.

• Brand Name: AIRSEAL 8/120MM PORT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 12526483
• MDR Text Key: 273165137
• Report Number: 3007305485-2021-00378
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Catalogue Number: IAS8-120LP
• Device Lot Number: 202011284
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/11/2021
• Patient Sequence Number: 1