MAUDE Adverse Event Report: COVIDIEN LP ABLATION GENERATOR X1

Model Number CAGEN1

Device Problems Loose or Intermittent Connection (1371); Unstable (1667); Noise, Audible (3273)

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

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The customer reported that prior to the procedure, the hospital biomed noticed a rattling sound inside the unit.He opened the cover of the unit and found a loose screw.He put the unit back together.When the surgeon tried to use the unit for a percutaneous ablation case, it malfunctioned and wouldn't work properly.It powered up but the display was blinking on and off.The antenna had already been placed in the patient who was under conscious sedation, but the ablation never started.The antenna was removed and the procedure stopped.There was no injury to the patient.The patient was rescheduled.

Manufacturer Narrative

(b)(4).Date of initial report: 11/11/2015.Date of follow-up report: 06/21/2016.Evaluation of the incident generator confirmed a screw was loose inside the unit.The cause of the loose screw could not be determined.The screw was replaced and threadlock was reapplied to address the condition.The generator was calibrated and tested and found to function properly.Review of the device history records found the generator had been released meeting all specifications.

• Brand Name: ABLATION GENERATOR X1
• Type of Device: ABLATION GENERATOR
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2044925267
• MDR Report Key: 5217256
• MDR Text Key: 31205985
• Report Number: 1717344-2015-00807
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAGEN1
• Device Catalogue Number: CAGEN1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1