MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) INTACT GEN1 WAND 15 MM; INSTRUMENT, BIOPSY

Model Number 777-115BT

Device Problems Melted (1385); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

Product analysis #(b)(4): brief description of complaint: the wire broke, and metal pieces were left inside the breast.Investigation conclusion: the reported issue was confirmed.There is one wire break within the multi-leaf element, which visually relates to the reported complaint description.The polyimide tubing of the broken wire is slightly separated from the stew leaf.The confinement sleeve, trocar tip legs are melted and degraded, however, it cannot be determined what caused the damage to the wand.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 intact wire fractured and detached.Wire fragments remained in the patient; however there was no adverse effect to the patient.

• Brand Name: INTACT GEN1 WAND 15 MM
• 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: 7575538
• MDR Text Key: 110320168
• Report Number: 1226420-2018-00162
• 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
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: 777-115BT
• Device Catalogue Number: 777-115BT
• Device Lot Number: EIT15C03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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 Age: 58 YR
• Patient Weight: 65