MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) 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 04/23/2018

Event Type  malfunction  

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 bles procedure, the wire on the intact wand fractured and detached.The wire remained in the patient with no adverse effect reported.

Manufacturer Narrative

Brief description of complaint: one of the wires between the struts on the wand broke during activation.It was noted that specimen was left inside the breast tissue.Investigation conclusion: the reported issue was not confirmed.The complaint lab intact¿ wand was inserted into the returned intact¿ handle and the activation button was depressed for deployment, which resulted in a successful air capture and a successful motorhome sequence at the end of the capture, confirming the handle functions as intended.There is no indication that the handle contributed to the damages alleged regarding the wand's broken wire.The handle was observed to have putty paste along the seam that presumably was used to secure the handle halves back together.However, it cannot be determined when this took place, as there has been a personnel change within the complaint lab investigation team and prior analysis data from the initial return date is no longer available.If information is provided in the future, a supplemental report will be issued.

Event Description

During a bles procedure, the wire on the intact wand fractured and detached.The wire remained in the patient with no adverse effect reported.

Manufacturer Narrative

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

• Brand Name: INTACT HANDLE
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: kaylee boisvert ; 180 international drive; portsmouth, NH 03801 ; 6038426234
• MDR Report Key: 7533447
• MDR Text Key: 108900703
• Report Number: 1226420-2018-00144
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• 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: 05/14/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 60