AQUAMANTYS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-30 for AQUAMANTYS manufactured by Medtronics.

Event Text Entries

[21545658] Pt undergoing right total knee surgery and when surgeon moved right leg from supine to flexed position to check for any bone fragments, aquamantys device fell down under pts foot and button depressed causing a scald burn. There is no recessed button on this piece of equipment or safety device to prevent accidental depression of button. According to (b)(6), this was the third burn from this product they have had in one year. Our concern is twofold, the normal holsters we have are to short for this piece of equipment and medtronics does not provide a more secure holster that button can't be accidentally depressed. We spoke to the representative of medtronic regarding the fact that there is no safety device around this button to prevent accidental depression and to bring it back to the company for review. It was also been noted that even if this device is in our holsters and some accidentally presses up against the area they can also get burned. From a clinician standpoint we are making sure everyone is diligent about making sure the equipment is placed off the surgical field and in its holster or table after use.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5040587
• MDR Report Key: 4491506
• Date Received: 2015-01-30
• Date of Report: 2015-01-30
• Date of Event: 2014-10-27
• Date Added to Maude: 2015-02-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AQUAMANTYS
• Generic Name: SEALER
• Product Code: DWG
• Date Received: 2015-01-30
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONICS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2015-01-30