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

Model Number SE3695

Device Problem Self-Activation or Keying (1557)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

An investigation of the reported condition was performed.A complaint of the device maintaining the suction permanently was reported.The suction should be activated only at the moment when a diathermal burn is performed.One device was received as a service request and a visual inspection and functional test were performed by the field service team.A dhr review was completed for serial# (b)(4).There were no manufacturing issues related to the complaint for this serial number.According to the technician, the unit works as intended.Additionally, the motor was found to be burned and needed replacement.The firmware was already updated to 1.18.The device as received met the specifications and passed functional testing for the suction capability.It failed for the motor component.This complaint will be considered as unconfirmed for issues with the suction.A root cause for the motor issue is wear and tear.The unit has exceeded its useful life.As part of continuous improvement efforts and a corrective action, the motor was replaced.The device was fully checked for functionality and patient electrical safety according to norm 60601 cl-1 and the manufacturer's guideline.It was deemed technically efficient and safe to use.The unit was cleaned and disinfected according to the manufacturer's guideline.If additional information is received, the investigation will resume as needed.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during testing, when the forceps button on the front panel is chosen the device maintains the suction permanently.The suction should be activated only at the moment when a diathermal burn is performed.There was no patient involvement.

• Brand Name: RAPIDVAC
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow drive; boulder CO 80301
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 8246186
• MDR Text Key: 133041279
• Report Number: 1717344-2019-00090
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10884524001753
• UDI-Public: 10884524001753
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2019

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: 12/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2001
• 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