MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC INTACT HANDLE; INSTRUMENT, BIOPSY

Model Number 777-001E

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: the wire basket broke during activation.The lesion was not removed, the wire broke into the breast and a piece was left in the breast, a piece of the wire detached from the wand and remains in the patient.There was no issue reported with the handle.Investigation conclusion: the reported issue was not confirmed.The returned handle failed to activate upon depression of the activation button, but it cannot be determined what caused the activation failure.Since the handle was not operational, the relationship of the handle to the reported complaint could not be determined.It was noted that the inside of the handle contained dried blood, specifically on the metal electrical contacts and other internal components.The possibility exists that the presence of blood could compromise handle and wand functionality.Similar events have concluded that blood in the handle could result in electrical continuity issues (wand detection, motor current) or mechanical issues (motor drive shaft).In conjunction with this complaint, the presence of blood was not directly attributed to the activation failure of the wand.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 HANDLE
• 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: 7266157
• MDR Text Key: 99899098
• Report Number: 1226420-2018-00043
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777-001E
• Device Catalogue Number: 777-001E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 04/13/2018
• 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