MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC AQUAMANTYS 6.0 BIPOLAR SEALER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	23-112-1
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a manufacture representative (rep) regarding a handpiece.It was reported that the site received a handpiece and its sterile seal was broken.It was no longer sterile.There was no patient involved.

• Brand Name: AQUAMANTYS 6.0 BIPOLAR SEALER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• MDR Report Key: 11405910
• Report Number: 1226420-2021-00055
• Device Sequence Number: 4568740
• Product Code: GEI
• UDI-Device Identifier: 00763000280888
• UDI-Public: 00763000280888
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K052859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2025
• Device Model Number: 23-112-1
• Device Catalogue Number: 23-112-1
• Device Lot Number: PHL100G0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1