MAUDE Adverse Event Report: COVIDIEN LP COOL-TIP RF SYS 100V ENG; RF ABLATION ACCESSORY

Model Number CTRF100

Device Problem Energy Output Problem (1431)

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

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported condition was confirmed.The investigation isolated the failure to the audio board, but a root cause was not identified.The probable root cause could not be determined based on the information provided.The audio board was replaced to address the condition.No trend has been identified.

Event Description

The customer reported that during an rf ablation procedure for liver cancer of 5mm s8 tumor, the unit was powered on and the needle was punctured.Resistance value was shown at 100 ohm but the output was below 7w and an error occurred.The needle was replaced but the incident occurred again.The patient was scheduled for a hepatectomy via open procedure.The team was going to ablate during the open procedure when the generator failed.

Manufacturer Narrative

One cool-tip audio board was received for evaluation.A visual inspection of the audio board found the torque seal on potentiometers p1, p2, p3, p4, and p7 through p12 had been removed.This may indicate that the potentiometers factory settings had been altered.The visual inspection found no other anomalies.The audio board was placed in cool-tip test unit.At initial power up, the test unit failed self-test by producing an impedance test failure.An impedance calibration was performed.At next power up the test unit passed self-testing.Testing found that the board would not accept calibration.Troubleshooting could not determine the cause of the calibration failures.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that during an rf ablation procedure for liver cancer of 5mm s8 tumor, the unit was powered on and the needle was punctured.Resistance value was shown at 100 ohm but the output was below 7w and an error occurred.The needle was replaced but the incident occurred again.The patient was scheduled for a hepatectomy via open procedure.The team was going to ablate during the open procedure when the generator failed.

• Brand Name: COOL-TIP RF SYS 100V ENG
• Type of Device: RF ABLATION ACCESSORY
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow dr.; boulder, CO 80301 ; 2034925267
• MDR Report Key: 6074405
• MDR Text Key: 59036394
• Report Number: 1717344-2016-01012
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K973297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2016

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: CTRF100
• Device Catalogue Number: CTRF100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2008
• 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