MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) AQUAMANTYS ENDO DBS 8.7; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	23-317-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
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 upon passing the handpiece device to the surgical field and being connected to the equipment, the doctor performed the functional test with the button and found that the metal stem was rotating on its axis, then they tested it to coagulate and realize that it was not there.Working and because there was no passage of energy, the doctor decided not to use it and remove it from the surgical field.Additional information was received and it was noted that the tip did not break off from the handpiece.The functional test with the button and found that the metal stem was rotating on its axis, then they tested it to coagulate and realize that it was not there.Both cut and coag never worked because the metal part was not making contact with the handpiece.The generator was working well.There was no patient involve.
Additional Manufacturer Narrative
H3: analysis summary: complaint confirmed: upon receiving the package, it was observed there were dried blood on the prongs of the device.It was also observed the shaft of the device was loose and was not in the correct placement when assembled.The shaft of the device was still intact and protruding from its assembled position when arrived but not enough to where it can ¿spin on its axis¿ as stated in the reported description.Upon observing the shaft, the residue and marks on the shaft that connects the metal shaft to the outer housing indicates the device was assembled properly in manufacturing defined in it's procedure.The device was still tested for its functionality and connected to the complaint lab fluke multimeter and confirmed the device has an closed circuit and produces energy when the coagulation button is depressed.The device was also connected to the complaint lab aex generator rather than the reported aqm generator due to it being end of life and not able to do the necessary pm¿s.The device had no issues with connecting and activating on chicken upon testing the device for its functionality.The device coagulated as expected and had no issues when tested for its functionality as reported in the description.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AQUAMANTYS ENDO DBS 8.7
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 11832286
• Report Number: 1226420-2021-00089
• Device Sequence Number: 11709580
• Product Code: GEI
• UDI-Device Identifier: 00763000280956
• UDI-Public: 00763000280956
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K181257
• 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,Followup
• Report Date (Section B): 10/13/2021

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: 07/22/2023
• Device Model Number: 23-317-1
• Device Catalogue Number: 23-317-1
• Device Lot Number: PHG220G0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1