MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC INTACT CONSOLE (GEN 1); INSTRUMENT, BIOPSY

Model Number 777-002

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

Product event: (b)(4).Patient information incomplete and missing patient information unable to be obtained despite a good faith effort made to obtain the information from the customer.If information is provided in the future, a supplemental report will be issued.

Event Description

During a breast lesion excision system case, the intact wire basket fractured and detached from the device.The detached wire remained in the patient, however there was no patient adverse effect reported.

Manufacturer Narrative

Product analysis #(b)(4).Brief description of complaint: report indicates that the wire basket broke during activation.The total lesion was removed, but foreign body was left within the breast investigation conclusion: the reported issue was not confirmed.The unit failed functional testing, as the voltage output is low across the 300 ohm load.The wire break issue could not be confirmed due to the functional failure found of low output.The low output was not part of the initial customer compliant, however may have contributed to the broken wire.Motor voltages during rf activation were also found to be slightly below comparative averages across 300 and 500 ohm loads.Adjusting the pid circuit voltage would likely restore functionality.However, the generator is not serviceable and has been designated to be scrapped.The following additional observations of this generator are as follows: audible tones are present, but volume cannot be adjusted.It has a metal plug instead and labeling is different from other gen 1s.The handle connector is assembled incorrectly, possibly because this was an early version of gen 1.Labeling has no impact on functionality of the system.Handle assembly also had no impact on functionality.It is unknown if these observations were within specification at the time of release of this product.If information is provided in the future, a supplemental report will be issued.

Event Description

During a breast lesion excision system case, the intact wire basket fractured and detached from the device.The detached wire remained in the patient, however there was no patient adverse effect reported.

• Brand Name: INTACT CONSOLE (GEN 1)
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• Manufacturer Contact: kaylee boisvert ; 180 international drive; portsmouth, NH 03801 ; 6038426234
• MDR Report Key: 7266134
• MDR Text Key: 99899423
• Report Number: 1226420-2018-00041
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K142477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777-002
• Device Catalogue Number: 777-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 56