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

Model Number	CA15L2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during procedure, the tip of the antenna broke and remained inside the patient.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found the ceramic tip is missing from the device.The tip was not returned.The reported condition was confirmed.The investigation found the ceramic tip was missing on the returned device.The investigation could not determine the root cause of the customer's report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during liver ablation, they first discovered that the tip was broken when they pulled out the antenna, there was no error message on the display during the procedure, and the tip of the antenna remained inside the liver in the fourth lesion.Patient is feeling well with no complications.

• 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; CN 201114
• MDR Report Key: 8276665
• Report Number: 3006451981-2019-00020
• Device Sequence Number: 158709
• Product Code: NEY
• UDI-Device Identifier: 10884521706583
• UDI-Public: 10884521706583
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K163105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 07/19/2020
• Device Model Number: CA15L2
• Device Catalogue Number: CA15L2
• Device Lot Number: S8JG011LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 03/21/2019
• 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: 55 YR