MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL IFS, 110V; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number AS-IFS1

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

Patient Problem Laceration(s) (1946)

Event Date 04/17/2017

Event Type  Injury  

Manufacturer Narrative

The user facility has stated that they do not attribute this laceration of the posterior spleen to the use of the airseal products.According to the hospital representative the surgeon was just venting when she blamed the airseal products for the laceration of the posterior spleen.As reported, the airseal ifs, 110v remains in use at the user facility.As of this filing, an investigation remains in progress.A supplemental and final report will be filed upon the completion of the complaint investigation.

Event Description

A conmed representative attended a robotic hysterectomy performed on (b)(6) 2017.The conmed airseal system was used and included the airseal ifs, 110v, a 12mm access port and palm grip obturator and a tri-lumen filtered tube set.During the procedure, the posterior spleen was lacerated resulting in splenic hemmorrhage.The conmed representative was asked to leave the room and the procedure converted to open approach.A splenectomy was performed.No further patient status information has been provided.This report is being filed based upon the surgeon verbally attributing this injury to the use of the airseal system.

Manufacturer Narrative

The device will not be returned for evaluation therefore any reported failure of this device cannot be confirmed.Although, this event was originally alleged to have been caused by airseal products, it was later reported by the hospital that the information provided was inaccurate.Spleen laceration was not related to the use of airseal products.The hospital will not be returning the device, instead the device will remain in use at the facility.Based on the serial number provided, the airseal ifs device was manufactured in 2006.There have been no other similar reports for this device and failure mode per a two-year review of complaint history.According to the instructions for use, the user is advised that improper use of this product can result in life-threatening injury to internal organs and vessels.Ensure that the patient is properly positioned so that organs are away from the penetration site.Direct the access port's tip away from significant vessels and organs.Do not use excessive downward force.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE; 4531 36th st; orlando FL 32811
• Manufacturer Contact: denise curtis ; 11311 concept boulevard; largo, FL 33773 ; 7273995421
• MDR Report Key: 6568527
• MDR Text Key: 75224334
• Report Number: 3006217371-2017-00009
• Device Sequence Number: 1
• Product Code: GCJ
• 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
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

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: Physician
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2017
• 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
• Treatment: ASM-EVAC
• Patient Outcome(s): Required Intervention