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

Model Number ASM-EVAC

Device Problems Misconnection (1399); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2022

Event Type  malfunction  

Event Description

Leur lock tip of tubing would not connect.Tip of tubing misshaped and would not allow connection.

• Brand Name: AIRSEAL
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 15515326
• MDR Text Key: 300896441
• Report Number: 15515326
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ASM-EVAC
• Device Catalogue Number: ASM-EVAC
• Device Lot Number: 2022053112
• 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: 09/20/2022
• Date Report to Manufacturer: 09/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA