MAUDE Adverse Event Report: CONMED CHIHUAHUA AIRSEAL 12/120MM LPI PORT; INSUFFLATOR, LAPAROSCOPIC

Model Number IAS12-120LPI

Device Problem Material Fragmentation (1261)

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Additional fda product code: gcj manufacturer narrative: the device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.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

The sales representative reported on behalf of the customer that the device, ias12-120lpi, was being used on (b)(6) 2021 during a robotic assisted laparoscopic gastric bypass procedure and ¿the rubber gasket/piece of the 12mm airseal access port sound cap split and fell into the patient as they were inserting the stapler.They were able to remove the pieces laparoscopically with no harm to the patient." there was no delay and the procedure was completed.After further assessment, it was found that the event happened when the surgical resident inserted a covidien laparoscopic stapler through the port.The resident felt that the tip of the stapler load caught the rubber and essentially split it into two pieces.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Event Description

The sales representative reported on behalf of the customer that the device, ias12-120lpi, was being used on (b)(6) 2021 during a robotic assisted laparoscopic gastric bypass procedure and ¿the rubber gasket/piece of the 12mm airseal access port sound cap split and fell into the patient as they were inserting the stapler.They were able to remove the pieces laparoscopically with no harm to the patient." there was no delay and the procedure was completed.After further assessment, it was found that the event happened when the surgical resident inserted a covidien laparoscopic stapler through the port.The resident felt that the tip of the stapler load caught the rubber and essentially split it into two pieces.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event is confirmed.The rubber gasket piece of the cap split into two pieces was confirmed based on photographic evidence.The device will not be returned, but photographic evidence provided appears to confirm the issue.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.A two-year review of complaint history revealed there has been a total of 19 complaints, regarding 19 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: if using the optional sound cap (8mm, 12mm): inspect sound cap foam and seal prior to use; use caution when inserting a sharp or large device through the blue sound cap seal and 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.

• Brand Name: AIRSEAL 12/120MM LPI PORT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED CHIHUAHUA; alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 12384804
• MDR Text Key: 268711283
• Report Number: 3007305485-2021-00324
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 10845854045688
• UDI-Public: (01)10845854045688(17)240425(10)202104264
• Combination Product (y/n): N
• PMA/PMN Number: K143404
• 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: 09/13/2021

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: 04/25/2024
• Device Model Number: IAS12-120LPI
• Device Catalogue Number: IAS12-120LPI
• Device Lot Number: 202104264
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 09/13/2021
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 106