MAUDE Adverse Event Report: CONMED SURGIQUEST AIRSEAL IFS; INSUFFLATOR

Model Number AS-IFS1

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Information (3190)

Event Date 06/16/2016

Event Type  malfunction  

Event Description

The manufacturer of the device refuses to provide the documentation required by (b)(6).Our authority having jurisdiction ((b)(6)) requires us to adopt the (b)(6) standards, therefore, we cannot be incompliance with our state health department requirements.They will not provide calibration instructions, planned maintenance instructions, schematics, theory of operation, etc.Which is spelled out in the (b)(6) standards.

• Brand Name: SURGIQUEST AIRSEAL IFS
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): CONMED; milford CT 06460
• MDR Report Key: 5737921
• MDR Text Key: 47905339
• Report Number: MW5062941
• Device Sequence Number: 1
• Product Code: HIF
• 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: 06/16/2016

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: AS-IFS1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2016
• Type of Device Usage: N
• Patient Sequence Number: 1