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

Model Number ASM-EVAC1

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2018

Event Type  malfunction  

Event Description

The tubing would not insufflate and airseal mode would not activate.

• Brand Name: AIRSEAL
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 7442878
• MDR Text Key: 105918050
• Report Number: 7442878
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2018

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: No Information
• Device Model Number: ASM-EVAC1
• Device Catalogue Number: ASM-EVAC1
• Device Lot Number: 17118
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR