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

Model Number ASM-EVAC1

Device Problems Gas/Air Leak (2946); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2022

Event Type  malfunction  

Event Description

Surgical airseal tubing came defective from packaging.Airseal is leaking air from connection tubing at sterile field.Tubing placed in original package and placed in biohazard bag and given to front desk for airseal rep to be notified.

• Brand Name: AIRSEAL
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 16371099
• MDR Text Key: 309485987
• Report Number: 16371099
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• 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: 202206204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2023
• Event Location: Home
• Date Report to Manufacturer: 02/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Female