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

Catalog Number IAS8-120LP

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

Additional product code; gcj h10: at time of filing, although expected, the reported device has not been received into conmed¿s complaint system for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and 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 ias8-120lp, airseal 8/120mm port, lot 202107235 that ascension health ministry / providence medical center recently experienced on (b)(6) 2021.Information indicates the issue occurred during a total hysterectomy.It was reported that the plastic seal between trocar and cap detached and fell into the patient¿s abdomen.It was noted 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.

Event Description

On behalf of the customer, the conmed representative reported issues with the ias8-120lp, airseal 8/120mm port, lot 202107235 that (b)(6) medical center recently experienced on (b)(6) 2021.Information indicates the issue occurred during a total hysterectomy.It was reported that the plastic seal between trocar and cap detached and fell into the patient¿s abdomen.It was noted 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.

Manufacturer Narrative

Investigation of the customer's complaint is confirmed.Conmed received one ias8-120lp returned opened in original packaging.The lot number of the device, 202107235, was verified based on returned packaging.A visual inspection found the duckbill had detached from the sound cap.The duckbill was not returned with the device.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.Use extreme caution during airseal access port insertion.Improper use of this product can result in life-threatening injury to internal organs and vessels.This issue will continue to be monitored through the complaint system to assure patient safety.

• 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
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: tracey weiselbenton ; conmed corporation; 11311 concept blvd; largo, FL 33773 ; 7273995557
• MDR Report Key: 12532977
• MDR Text Key: 273341821
• Report Number: 3007305485-2021-00383
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAS8-120LP
• Device Lot Number: 202107235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic