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

Model Number	CA20L1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/08/2018
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, during procedure, the needle was broken and only connected with other part through ceramic coating, due to this tumor was not ablated.Consultant continued the procedure, but lesion was not covered and consultant rescheduled the procedure.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found that part of the outer antenna shaft was broken.The broken piece was still attached.The reported condition was confirmed.This break is consistent with the user exceeding the shaft bend radius limit.The investigation identified the root cause of the reported event to be user error.The instructions for use (ifu) states, 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.

• 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: 8124030
• Report Number: 3006451981-2018-00644
• Device Sequence Number: 16567412
• Product Code: NEY
• UDI-Device Identifier: 10884521189546
• UDI-Public: 10884521189546
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K133821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 12/26/2019
• Device Model Number: CA20L1
• Device Catalogue Number: CA20L1
• Device Lot Number: S7MG027PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 02/28/2019
• 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