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

Model Number ASM-EVAC1

Device Problem No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 12/23/2021

Event Type  malfunction  

Event Description

Opened airseal tubing for robotic case.Turned on insufflation, but there was no co2 flow.Checked co2 connections.Called biomed.Biomed in operating room.

• Brand Name: AIRSEAL
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 14731275
• MDR Text Key: 294254464
• Report Number: 14731275
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 10845854045435
• UDI-Public: (01)10845854045435(17)241014(10)202110154
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ASM-EVAC1
• Device Catalogue Number: ASM-EVAC1
• Device Lot Number: 202110154
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: Black Or African American