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

Model Number 120CE723

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Pneumothorax (2012)

Event Date 02/25/2016

Event Type  malfunction  

Event Description

The patient had a pneumothorax along with subcutaneous edema.Manufacturer reported to fda also.Manufacturer response for surgiquest airseal system (intelligent flow system), surgiquest airseal system (per site reporter): known risk of insufflator from pressure from c02.

• Brand Name: AIRSEAL IFS
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 5735051
• MDR Text Key: 47706885
• Report Number: 5735051
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/26/2016,06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 120CE723
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LAPAROSCOPIC NISSAN FUNDOPLICATION PROCEDURE USING
• Patient Outcome(s): Other
• Patient Age: 64 YR