MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL IFS, 110V; AIRSEAL INSUFFLATOR

Catalog Number AS-IFS1

Device Problem Inflation Problem (1310)

Patient Problem Blood Loss (2597)

Event Date 07/10/2017

Event Type  Injury  

Manufacturer Narrative

The reported airseal ifs was not returned to conmed for evaluation as it was discarded by the user facility; therefore, a root cause was unable to be determined.Based on the information provided by the facility, in many instances, a fair amount of bleeding over the course of the procedure is normal.On rare occasions, excessive bleeding may occur, which would require a blood transfusion.This device is manufactured by w.O.M.Thus manufacturing documents were unable to be reviewed.Based on the serial number, this device was manufactured in 2015 and has no prior service history.A two-year review of complaint history revealed 22 similar complaints have been reported for this device family.(b)(4).A risk analysis was performed and was deemed acceptable.The airseal® ifs system is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke.It is indicated to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it by creating and maintaining a gas sealed, obstruction free path and by evacuating surgical smoke.To reduce the risk of patient injury, the as-ifs instructions for use (ifu) provides the following warnings: 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.These instructions for use do not include descriptions or instructions for surgical techniques or laparoscopic procedures.It is the responsibility of the physician performing any procedure to determine the specific technique for each patient.This incident type will continue to be monitored through the complaint system to assure patient safety.

Event Description

The user facility reported during a laparoscopic hysterectomy the airseal ifs shutdown and was unable to be restarted.The surgeon inserted a 10 mm tenaculum through the 8 mm access port and grasped the uterus to manipulate it.While pulling on the tenaculum and uterus, the airseal ifs shut down, pneumo was lost and the device was unable to be restarted.They tried to re-establish pneumo with the airseal setup guide but were unsuccessful.Using an alternative device, the procedure was successfully completed with a 15-minute delay.Additionally, the patient was reported to have lost a fair amount of blood during the procedure.The patient required a blood transfusion post surgery and is recovering as projected.This report is raised on this basis of the reported unanticipated blood transfusion that was required post surgery.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: AIRSEAL INSUFFLATOR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• Manufacturer (Section G): W.O.M. - WORLD OF MEDICINE; 4531 36th st; orlando FL 32811
• Manufacturer Contact: lindsey sheppard ; 525 french road; utica, NY 13502 ; 7273995209
• MDR Report Key: 6876592
• MDR Text Key: 86638300
• Report Number: 3006217371-2017-00019
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 53 YR