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

Model Number	CA15L2
Medical Device Problem Codes	Connection Problem (2900); Temperature Problem (3022)
Health Effect - Clinical Codes	Hemothorax (1896); No Code Available (3191)
Date of Event	09/27/2018
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, the device was used for lung malignant tumor.Activation was started with antenna, but temperature error occurred immediately after the activation started.The saline was checked, and it was at room temperature.To specify which one of the antennas and the generator was the cause, a new antenna was used, and its activation was checked, and it could be activated without problem.After that, a new antenna was used, and this time the error "antenna not detected" occurred simultaneously when powering on.Connected the first antenna for a trial, and the error "antenna not detected" also occurred.Because the generator was not stable, rf ablation was decided to be performed according to the doctor's judgment.The tumor seemed to be ablated, but complications (hemothorax) occurred and at present the patient was under observation.The surgical time was extended, and reoperation was require d due to the issue.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found one of the pins in the connector was bent.The reported condition was confirmed.A pin in the cable connector was found to be bent.The pin may have been bent when the antenna was assembled to the cable during use.The bent pin caused the antenna not to be recognized.Since the pin was bent, the antenna could not be functionally tested.The investigation identified the root cause of the reported event to be user error.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: 7990020
• Report Number: 3006451981-2018-00616
• Device Sequence Number: 1669864
• Product Code: NEY
• UDI-Device Identifier: 10884521706583
• UDI-Public: 10884521706583
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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: 07/01/2020
• Device Model Number: CA15L2
• Device Catalogue Number: CA15L2
• Device Lot Number: S8GG001X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 01/02/2019
• 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: Required Intervention