MAUDE Adverse Event Report: CONMED CORPORATION RAPIDVAC; APPARATUS, EXHAUST, SURGICAL

Model Number	SE3695
Medical Device Problem Codes	Break (1069); Fire (1245); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the inlet area was burned and plastic insulations melted.It was reported that the cord on the device failed or was damaged, and a device had an internal component failure.The reported issues were confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the unit had severe burning and damage to main cable proximal to unit: damage to iec main input connector such as melted plastic and neutral pin damage.There was no patient injury.No further information available.The medtronic initial visual investigation showed that the inlet area was burned and plastic insulations melted.

• Brand Name: RAPIDVAC
• Common Device Name: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 5900 genesee st; lancaster NY 14086
• Manufacturer (Section G): CONMED CORPORATION; 5900 genesee st; lancaster NY 14086
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12890023
• Report Number: 1717344-2021-01586
• Device Sequence Number: 17234478
• Product Code: FYD
• UDI-Device Identifier: 10884524001753
• UDI-Public: 10884524001753
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K980915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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: SE3695
• Device Catalogue Number: SE3695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown