MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) AQUAMANTYS 9.5 XL BIPOLAR SEALER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	23-313-1
Medical Device Problem Code	Failure to Shut Off (2939)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
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 during surgery, there was a problem with the handpiece button, where it did not stop working and the tweezers remained working uninterruptedly, the product warmed up and the button did not turn off.It was necessary to open another handpiece to solve the problem.There was no patient impact.

• Brand Name: AQUAMANTYS 9.5 XL BIPOLAR SEALER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 12109194
• Report Number: 1226420-2021-00108
• Device Sequence Number: 3775069
• Product Code: GEI
• UDI-Device Identifier: 00643169868250
• UDI-Public: 00643169868250
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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: 09/21/2024
• Device Model Number: 23-313-1
• Device Catalogue Number: 23-313-1
• Device Lot Number: PHI239F0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1