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

Device Problems Device Alarm System (1012); Medical Gas Supply Problem (2985)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2021

Event Type  malfunction  

Event Description

Lost abdominal pneumoperitoneum during robotic procedure.Conmed's airseal system alarmed gas low.Gas tank was changed and machine continued to alarm.A second gas tank was changed and continued to alarm as low.Machine was restarted and surgical case continued with no further issues.

• Brand Name: AIRSEAL
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 11982399
• MDR Text Key: 255635501
• Report Number: 11982399
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/03/2021

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA