MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	CA20L2
Medical Device Problem Codes	Device Alarm System (1012); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an ablation procedure, the catheter was placed in the correct position (in the liver) by the physician, the generator was on the catheter connected, the wattage was set to 80, and the time was set to four minutes.The nurse pressed the start button but the generator failed to activate and it was giving the general warning code.They pressed the restart button, and repeated the process twice but still nothing happened.They waited a few more minutes and repeated the process one more time, then checked the tubing, the connections, and restarted the procedure at the same 80 watts and four minutes but still nothing happened.After consulting the manual, the physician decided to wait six minutes and again restarted the procedure and still nothing happened.The general warning alarm occurred on each attempt.The alarm was activated when they pressed the ¿start/stop¿ button on the g enerator.The catheter did not activate, it never started at all.After a few more attempts the physician decided to abort the procedure withthe patient still under anesthesia.

• Brand Name: EMPRINT
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• MDR Report Key: 11094941
• Report Number: 3006451981-2020-00199
• Device Sequence Number: 17203155
• Product Code: NEY
• UDI-Device Identifier: 10884521706590
• UDI-Public: 10884521706590
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K163105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2020
• Device Model Number: CA20L2
• Device Catalogue Number: CA20L2
• Device Lot Number: S8LG006X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR