MAUDE Adverse Event Report: W.O.M. - WORLD OF MEDICINE AIRSEAL IFS, 110V

Catalog Number AS-IFS1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Death (1802)

Event Date 12/01/2017

Event Type  Death  

Manufacturer Narrative

As reported, the device did not malfunction.The device remains in use at the facility and will not be returned for evaluation.The cause of death was stated to be a cerebrovascular accident, which pertains to the brain and its blood vessels.A two-year review of complaint history revealed no prior complaints involving this device with a patient death.This device will continue to be monitored through the complaint system to assure patient safety.

Event Description

A user facility reported an airseal device and 12x100mm port were used during a colon resection.The flow was set at 20 and pressure at 15mmhg.The first insufflation was made using a veress needle and airseal port when the pressure reached 15.As the surgeon was placing the trocars in position, the anesthesiologist informed him the patient was not doing well and requested the insufflation stop until the patient was stabilized.A few minutes after this request, the patient was stable and insufflation began again at flow set 5 and pressure at 8mmhg.Pressure was after increased to 9-10-12-13 as per surgeon request.The anesthesiologist and surgeon discussed the patient status and determined the patient was responding well.After the trocars were put in place, the surgeon changed his approach from laparoscopic to open due to poor visibility and too many adherences.It was at this time the airseal unit was shut down and no longer used.The procedure was completed successfully.The patient was monitored in the pacu (post-anesthesia care unit) and suffered from a cerebrovascular accident and passed away.This report is raised on the basis of a conmed device being utilized in a procedure where the patient passed away during post-operative care.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: AIRSEAL
• Manufacturer (Section D): W.O.M. - WORLD OF MEDICINE; 4531 36th st; orlando FL 32811
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502
• Manufacturer Contact: lindsey sheppard ; 525 french road; utica, NY 13502 ; 7273995209
• MDR Report Key: 7139759
• MDR Text Key: 95544521
• Report Number: 3006217371-2017-00289
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2017

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: Other
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Weight: 36