MAUDE Adverse Event Report: LINVATEC CORPORATION D/B/A CONMED LINVATEC AIRSEAL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number IAS8-100LP

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/01/2018

Event Type  malfunction  

Event Description

When the surgeon was using the airseal product, several attempts were made to maintain insufflation but was unsuccessful.The surgeon aborted the product and used the insufflation product from the robot pack.This was a new device being used by this surgeon.The surgeon was trained on how to use this product.

• Brand Name: AIRSEAL
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): LINVATEC CORPORATION D/B/A CONMED LINVATEC; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 7372902
• MDR Text Key: 103583583
• Report Number: 7372902
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 03/15/2018

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: Physician
• Device Expiration Date: 10/17/2020
• Device Model Number: IAS8-100LP
• Device Catalogue Number: IAS8-100LP
• Device Lot Number: 91317
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2018
• 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
• Treatment: OTHER ROBOTIC EQUIPMENT
• Patient Age: 49 YR