MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS LEGEND DISSECTING TOOL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number DS1TD32L

Device Problem Scratched Material (3020)

Patient Problems Hematoma (1884); Visual Impairment (2138); Unspecified Tissue Injury (4559)

Event Date 06/10/2023

Event Type  Injury  

Manufacturer Narrative

H3: no conclusion can be drawn.No evaluation was performed, as the device was discarded at the customer's end.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It was reported that during the insertion of visualase laser fibre for ablation of brain area for epilepsy, subdural hematoma noticed on magnetic resonance imaging scans at cortical entry after patient taken to radiology department immediately post-insertion of visualase skull post and laser fiber.It was reported that the patient returned to operating theatre without performing laser ablation, and craniotomy to drain subdural hematoma.Health care profession observed that on the visualase skull post, which is screwed into the skull and holds the laser fibre in place.It was reported that on the day the post had felt loose when they had removed it and there was issue with sharpness of the tool thread.It was reported that patient remains hospitalized and approximately 50 percent vision impairment from subdural haematoma acquired during surgery.It was also reported that there was delay in procedure for ablation abandoned and to take back the patient to theatre for removal of visualase laser fibre, and craniotomy to drain subdural hematoma and the final part of procedure abandoned.

• Brand Name: LEGEND DISSECTING TOOL
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: glen belmer ; 7000 central avenue ne; ft. worth, TX 76137-3291 ; 6122713209
• MDR Report Key: 17348458
• MDR Text Key: 319287615
• Report Number: 1625507-2023-00172
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K020069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DS1TD32L
• Device Catalogue Number: DS1TD32L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 65 KG