MAUDE Adverse Event Report: MEDTRONIC XOMED INC. AQUAMANTYS GENERATOR (115V); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	40-402-1
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
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 GENERATOR (115V)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 11760563
• Report Number: 1045254-2021-00215
• Device Sequence Number: 4545722
• Product Code: GEI
• UDI-Device Identifier: 00643169078741
• UDI-Public: 00643169078741
• 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
• 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 Model Number: 40-402-1
• Device Catalogue Number: 40-402-1
• Was Device Available for Evaluation?: No
• 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