MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) AQUAMANTYS 2.3 BIPOLAR SEALER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	23-113-1
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis summary: complaint not confirmed: the device was tested for its functionality and observed for any sparks that were reported.The device met the products requirements with continuity and the saline flow rate.The device was also tested on raw chicken and following instructions from the ifu and concluded the device had no error messages that generated during the analysis and no failures were detected.No visible sparks were seen when tested for its functionality.The normal popping generated when the coagulation mode was depressed and not touching the chicken or in a pool of saline which is not recommended in the ifu.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 two generator and two handpieces.It was reported that during a sacroiliac and thoracolumbar procedure, the handpieces was excessively sparking.They tried switching the hand pieces and they were still getting excessive sparking.They decided to switch generators and still no resolution.They ultimately decided to not use the generator.There was no impact to patient outcome.

• Brand Name: AQUAMANTYS 2.3 BIPOLAR SEALER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 11760561
• Report Number: 1226420-2021-00085
• Device Sequence Number: 4662560
• Product Code: GEI
• UDI-Device Identifier: 00763000280895
• UDI-Public: 00763000280895
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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: 01/19/2026
• Device Model Number: 23-113-1
• Device Catalogue Number: 23-113-1
• Device Lot Number: PHA201N0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 42