MAUDE Adverse Event Report: COVIDIEN-PLYMOUTH GENERATOR WITH VERSION4.0.0 + 4.1.0; GENERATOR, LESION, RADIOFREQUENCY

Model Number RFG2

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2015

Event Type  malfunction  

Event Description

Customer states that during a radio frequency vein ablation procedure, the rf generator (rfg2) screen went black.Customer states they could no longer see or hear the unit during the ablation.This issue happened during a case but the ablation hadn't been started yet and then the procedure was aborted.

Manufacturer Narrative

A review of the manufacturing records for this device did not reveal any discrepancies relevant to the reported event.Additional information has been requested, should it become available a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

This mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.

Event Description

Customer states that during a rf vein ablation procedure, the rf generator (rfg2) screen went black.Customer states they could no longer see or hear the unit during the ablation.Customer states that they turned off the unit, turned the unit back on and still witnessed no power to the screen.This issue happened during a case and the procedure was aborted.There were also two other patients that day that had to be rescheduled.Customer would like to return the unit for service, and have a loaner unit sent out as soon as possible for rescheduled cases.Evaluation summary: the investigation confirmed the reported complaint.A true root cause of the failed component could not be determined.During power-up, screen is blank.The backlight inverter (s/n (b)(4)) was then replaced.Battery checked good at 3.03v.Verified correct cable ties.Upgraded output rating label (rm-55-911-01), upgraded rf cable s/n (b)(4) and upgraded software 4.4.0 to current version 4.6.0.Sk buttons are bad.Replaced horizontal keypad (891921000) and ui horizontal s/n (b)(4).Replaced vertical keypad (891920000) and ui vertical s/n (b)(4).Performed test functions according to mp-17566, mp-17567 and mp-17569.All tests passed.No further action was taken.

• Brand Name: GENERATOR WITH VERSION4.0.0 + 4.1.0
• Type of Device: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): COVIDIEN-PLYMOUTH; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN-PLYMOUTH; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: 15 hampshire st; mansfield, MA 02048 ; 33987000
• MDR Report Key: 4838503
• MDR Text Key: 5906361
• Report Number: 2183870-2015-00214
• Device Sequence Number: 1
• Product Code: GXD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFG2
• Device Catalogue Number: RFG2
• Device Lot Number: 111004004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 111