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

Catalog Number AS-IFS1

Device Problem Leak/Splash (1354)

Patient Problem Embolism (1829)

Event Type  No Answer Provided  

Manufacturer Narrative

Despite the follow-up attempts, the user facility declined to provide any additional information regarding this incident or the product return status.However, the hospital representative did state that even though the serial number of the involved unit was not made available to his office, he did indicate that the device would not be returned for evaluation.He further stated that all as-ifs units remain in use at the user facility with no problems reported.As of this filing, the investigation remains in progress, a supplemental and final report will be filed upon the completion of the complaint investigation.Device remains in use at user facility.

Event Description

The user facility reported that during use of the airseal ifs, 110v in a laparoscopic liver resection procedure, the anesthesiologist noticed a significant drop in etco2 and alerted the surgeon about gas embolus concern.The surgeon noticed quivering of the vena cava and immediately put the patient in steep trendelenburg position and desufflated the pneumoperitoneum.Embolus concern was addressed and the procedure was resumed and completed laparoscopically with no further complications or patient injury.Additionally, no patient post-operative impact reported.This report is filed on the basis of potential injury with recurrence.

Manufacturer Narrative

To date, the as-ifs1 airseal unit remains in use at the user facility with no problems reported.Without the involved device, an evaluation could not be performed and the root cause of the reported problem was unable to be determined.Based on available information, it is believed that the most probable cause of this "embolus concern" was due to a procedural technique issue.A review of the adverse event history for this device shows a total of two (2) reports received from the same surgeon/facility.This reported incident will continue to be monitored via the complaint system to ensure product safety.No further action is planned at this time.This failure mode is addressed in the dfmea, and the safety risk has been found to be 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 appropriateness of the type of procedure to be performed with the use of these products and to determine the specific technique for each patient.Device remains in use at user facility.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): SURGIQUEST, INC.; 488 wheelers farms road; milford CT 06461
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5845025
• MDR Text Key: 51119862
• Report Number: 3006217371-2016-00027
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

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: AS-IFS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/28/2016
• 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 Outcome(s): Other
• Patient Age: 36 YR