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

Model Number CA15L2

Device Problem Failure to Fire (2610)

Patient Problem No Information (3190)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during an ablation, the antenna did not activate because the generator and antenna had connection problems.The procedure was aborted due to this issue.

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 found one of the pins in the connector was bent.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 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.

Manufacturer Narrative

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 20111 4; CN 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer Contact: amy beeman ; 5920 longbow drive; boulder, CO 80301 ; 7632104064
• MDR Report Key: 7639169
• MDR Text Key: 112377802
• Report Number: 3006451981-2018-00476
• Device Sequence Number: 1
• Product Code: NEY
• UDI-Device Identifier: 10884521706583
• UDI-Public: 10884521706583
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K163105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA15L2
• Device Catalogue Number: CA15L2
• Device Lot Number: S8CG019PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention