MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER RAPIDVAC; APPARATUS, EXHAUST, SURGICAL

Model Number	SE3690
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2018
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
According to the reporter, during surgery, the device would not shut off.Another device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device sample was received as a service request and a visual inspection and functional test were performed by the supplier.A device history record review was completed.There were no manufacturing issues related.This product was being used for treatment.Inspection of the device resulted in determining that the returned unit operated normally.This complaint will be considered as unconfirmed.Further inspection revealed that the unit required replacement of the power entry module and insulation.The exact root cause of the failure could not be determined; however these items are subject to wear and tear with use.As part of continuous improvement efforts and a preventive action, the supplier repaired and returned the unit.If additional information is received, the investigation will resume as needed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RAPIDVAC
• Common Device Name: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow drive; boulder CO 80301 3299
• MDR Report Key: 7448732
• Report Number: 1717344-2018-00536
• Device Sequence Number: 2156984
• Product Code: FYD
• UDI-Device Identifier: 10884524001555
• UDI-Public: 10884524001555
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K142335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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: SE3690
• Device Catalogue Number: SE3690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1