MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) LIGHTED RESTRACTOR SOLSTICE B1; RETRACTOR

Model Number 50-101-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

(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 reconstruction case, the surgeon reported the teeth on the radialux blade caused "shredding of the muscle." the surgeon used a different size blade without teeth to complete the procedure and further interventions were needed for the patient.

• Brand Name: LIGHTED RESTRACTOR SOLSTICE B1
• Type of Device: RETRACTOR
• 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: 7496028
• MDR Text Key: 107649713
• Report Number: 1226420-2018-00119
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2019
• Device Model Number: 50-101-1
• Device Catalogue Number: 50-101-1
• Device Lot Number: Y767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2017
• 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