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

Model Number CA15L1

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that during insertion while holding the antenna by the shaft, the radiologist commented that the antenna was blunt and not easily manipulated.A slight bend at the distal 1/3 of the tip was noted.Regardless, the first lesion was punctured and the first cycle was performed.The radiologist proceeded with the second ablation cycle but during re-insertion and further antenna manipulation, the radiologist noted that the shaft was bent more than before.A minute into the second cycle, the radiologist noticed swelling of the skin at the puncture site and suspected the antenna was leaking water.The procedure was aborted due to cost.The swelling was compressed and gradually decreased over time.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection of the antenna revealed it is bent in the middle.All parts are still attached.No pieces were missing.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, to prevent damage to the antenna, it is highly recommended that a small skin incision be made prior to insertion.Use a scalpel or electrosurgical pencil to expand the insertion point if you meet resistance.Although the antenna is flexible, using force to break through an obstruction may lead to breakage and possible injury to the patient.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
• Type of Device: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai CO 20111 4; CN 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai CO 20111 4; CN 201114
• Manufacturer Contact: sharon murphy ; 5920 longbow dr.; boulder, CO 80301 ; 2034925267
• MDR Report Key: 7039807
• MDR Text Key: 92282614
• Report Number: 3006451981-2017-05771
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K133821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA15L1
• Device Catalogue Number: CA15L1
• Device Lot Number: S6LG010X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other