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

Model Number	CA15L1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
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 the microwave ablation procedure, the cooling line part of the probe was detached or separated from the probe.Therefore the case was completed by using another probe.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found the luer was broken between the orange and clear inflow tubing.The reported condition was confirmed.The investigation found the tubing leaked at the orange/clear tubing junction.The connector was broken.Post market vigilance (pmv) could not determine how or why the connector broke.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 the microwave ablation procedure, the cooling connection of the probe was broken, nothing fully detached with the device.Nothing fell into patients cavity.Therefore the case was completed by using another probe.There was no patient injury.
Additional Manufacturer Narrative
This report was generated manually.The report and text information has been reviewed and there is no new event or investigation information to provide at this time.This report is not necessary and will be cancelled.If information is provided in the future, a supplemental report will be issued.

• 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: 7822520
• Report Number: 3006451981-2018-00579
• Device Sequence Number: 11026177
• Product Code: NEY
• UDI-Device Identifier: 10884521189539
• UDI-Public: 10884521189539
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K133821
• 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,Followup
• Report Date (Section B): 11/27/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/18/2019
• Device Model Number: CA15L1
• Device Catalogue Number: CA15L1
• Device Lot Number: S7KG031X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/06/2018; 10/30/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 09/28/2018; 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1