MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC MEDTRONIC AQUAMANTYS XL BIPOLAR SEALER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number REF 23-313-1

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Event Description

Medtronic aquamantys 9.5 xl bipolar sealer (ref#23-313-1, lot #phj09900, exp 10/07/2024) connected to aquamantys power unit (ref#40-405-01, sn# (b)(4), hospital asset # (b)(6)) per manufacturer's recommendations at start of procedure.The above medtronic aquamantys 9.5 xl bipolar sealer blue power button jammed at 1020, and remained on for 10-12 seconds.Surgeon was able to release blue power button, but it became jammed for a second time at 1021.The above medtronic aquamantys 9.5 xl bipolar sealer was removed from sterile field, disconnected, and retained for evaluation in the original box.A new medtronic aquamantys 9.5 xl bipolar sealer (ref#23-313-1, lot #phg160f0, exp 7/15/2025) connected to the same aquamantys power unit (ref#40-405-01, sn# (b)(4), hospital asset # (b)(6)) per manufacturer's recommendations.No further equipment issues noted with the medtronic aquamantys 9.5 xl bipolar sealer, and the aquamantys power unit continued to function normally.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC AQUAMANTYS XL BIPOLAR SEALER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC
• MDR Report Key: 11107995
• MDR Text Key: 225176287
• Report Number: MW5098618
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: REF 23-313-1
• Device Lot Number: PHJ09900
• 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: 48 YR