MAUDE Adverse Event Report: CONMED CORPORATION CONMED AIRSEAL IFS SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Device Problems Material Discolored (1170); Failure to Power Up (1476); Inadequacy of Device Shape and/or Size (1583)

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

Event Date 10/15/2018

Event Type  malfunction  

Event Description

Air seal system shut off during use in a robotic case.Staff tried to cycle the power button and switch outlets but unit would not power back up.Upon further review, the power appeared to be interrupted at fuse block it appears that equipment fuse block is undersized for this type of machine.Pins of the block were discolored and oxidized which leads to interruption of power.Of note, this issue has been brought to company's attention twice before with no result.

• Brand Name: CONMED AIRSEAL IFS SYSTEM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 8032546
• MDR Text Key: 126219709
• Report Number: MW5081005
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR