MAUDE Adverse Event Report: CONMED CORPORATION SMOKEEVAC FILTERED TUBE SET; SMOKEEVAC TUBE SET

Catalog Number SEM-EVAC

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 04/27/2018

Event Type  Injury  

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.

Event Description

The conmed sales representative reported that during an inguinal hernia procedure, during smoke evacuation with the use of sem-evac, the patient suffered of subcutaneous emphysema.The procedure was completed with no reported surgical delays.To date, no additional information regarding the patient status or procedure has been made available.This report is raised on the basis of a reported patient injury.

Manufacturer Narrative

The device was not returned by the user facility and no photographic evidence was provided; therefore, the reported failure could not be verified and a root cause cannot be conclusively determined.Although multiple attempts have been made, no additional information regarding the patient status, procedure or need for additional treatment has been made available.The concomitant devices, as-ifs1, were tested and met pressure accuracy specifications.A review of manufacturing documents was not possible as the lot number for this product was not made available.A two-year review of complaint history revealed 2 similar complaints for this product family and failure mode.In that same timeframe, 47,016 units of this product family have been sold worldwide, making the rate of occurrence of this failure 0.006 percent, if all complaints were confirmed.The instructions for use advises the user of the following.Failure to properly follow the instructions for use can lead to serious surgical consequences.Only qualified physicians with knowledge, experience and training in laparoscopic techniques should use the components of the airseal access system.Higher insufflation pressures (greater than 15 mm hg) of carbon dioxide can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumothorax, pneumoscrotum and urinary retention.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: SMOKEEVAC FILTERED TUBE SET
• Type of Device: SMOKEEVAC TUBE SET
• Manufacturer (Section D): CONMED CORPORATION; 488 wheelers farms road; mildford CT 06461
• MDR Report Key: 7542728
• MDR Text Key: 109223023
• Report Number: 3006217371-2018-00127
• Device Sequence Number: 1
• Product Code: HIF
• 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,other
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SEM-EVAC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 07/03/2018
• Supplement Dates FDA Received: 07/06/2018
• Patient Sequence Number: 1
• Treatment: AS-IFS1, SERIAL (B)(4), CONMED; AS-IFS1, SERIAL (B)(4), CONMED
• Patient Outcome(s): Other