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

Model Number ASM-EVAC1-BI

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

Event Date 04/22/2024

Event Type  malfunction  

Event Description

During procedure, the airseal product/tubing did not hold pneumo and made abnormal hissing sound.

• Brand Name: AIRSEAL
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 19206359
• MDR Text Key: 341490964
• Report Number: MW5154378
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/23/2024

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-BI
• Device Lot Number: 2024013112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2024
• Patient Sequence Number: 1