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

Model Number ASM-EVAC1

Device Problems Connection Problem (2900); Gas/Air Leak (2946); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2021

Event Type  malfunction  

Event Description

Tubing attached to airseal device.Surgeon began insufflation and it seemed to be taking longer than normal.Insufflation limit reached.Airseal trochar attached to tubing.Once attached, the airseal machine began alarming.Air was noted coming out of machine around tubing connection.The tubing and set up were changed.The second set up worked fine.

• Brand Name: AIRSEAL
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 12312697
• MDR Text Key: 266203731
• Report Number: 12312697
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2021

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: Health Professional
• Device Model Number: ASM-EVAC1
• Device Catalogue Number: ASM-EVAC1
• Device Lot Number: 2021052011
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1