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

Model Number	CA15L1
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the shaft was broken.The evaluation found that the broken shaft is consistent with an external force on the shaft.It was reported that the device broke prior to use.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: do not apply excessive lateral or rotational force during insertion or extraction of the antenna.Doing so may lead to breakage of the antenna and injury to the patient or user.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, pre-operatively, upon unboxing, it was discovered that the serum line was detached from the device.The device was replaced prior to the patient being anesthesized.There was no patient involvement.Medtronic initial investigation found that the shaft was broken.The outer part of the shaft separated from the inner part.The broken piece was returned.

• 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: 11602275
• Report Number: 3006451981-2021-00048
• Device Sequence Number: 14275540
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2021

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: 10/16/2019
• Device Model Number: CA15L1
• Device Catalogue Number: CA15L1
• Device Lot Number: S7KG030X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1