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

Model Number SE3695

Device Problems Break (1069); Fire (1245); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 281382599
• Report Number: 1717344-2021-01586
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10884524001753
• UDI-Public: 10884524001753
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K980915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1