MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) AEX GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 40-405-1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

Product event: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

During the procedure, the aquamantys generator was activated with a hand piece and the settings spontaneously increased to the max setting.There was no patient injury or adverse effect reported.

Manufacturer Narrative

Product analysis: brief description of complaint: during the procedure, the aqm setting spontaneously increased to max setting.The staff re-set the power to 110, but it increased again, so they stopped using it.There were no error codes.Biomed confirmed the settings automatically increase as soon as the generator is turned on, even without a device connected.Investigation conclusion: the reported issue was confirmed.The generator failed the functional test, as adjustments to settings could not be performed due to a cracked lcd.The cracked lcd is consistent with settings interference or unintended adjustments, although neither was encountered during functional testing.Replacing the lcd restores normal functionality.Minor cosmetic damage to the enclosure, bezel, and rem receptacle assembly was also observed, but without a functional impact.Replacing the bezel and rem receptacle assembly and repairing the enclosure returns the unit to acceptable cosmetic standards.If information is provided in the future, a supplemental report will be issued.

Event Description

During the procedure, the aquamantys generator was activated with a hand piece and the settings spontaneously increased to the max setting.There was no patient injury or adverse effect reported.

• Brand Name: AEX GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: kaylee boisvert ; 180 international drive; portsmouth, NH 03801 ; 6038426234
• MDR Report Key: 7452128
• MDR Text Key: 106254909
• Report Number: 1226420-2018-00113
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

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: Health Professional
• Device Model Number: 40-405-1
• Device Catalogue Number: 40-405-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 59