MAUDE Adverse Event Report: CTL MEDICAL CORPORATION TAURUS; PROBE, SOUNDER, CURVED

Model Number 50-2000-001

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  malfunction  

Event Description

Curved probe sounder broke at distal end during a surgery and the tip was removed without incident.Part not returned.Pictures of part not provided.No pre or post-op x-rays were provided.No surgical technique used by the surgeon nor patient information were provided.Surgery was completed without incident.No harm or injury to the patient was reported.Cause indeterminate.

• Brand Name: TAURUS
• Type of Device: PROBE, SOUNDER, CURVED
• Manufacturer (Section D): CTL MEDICAL CORPORATION; 4550 excel pkwy; ste 300; addison TX 75001
• Manufacturer (Section G): CTL MEDICAL CORPORATION; 4550 excel pkwy; ste 300; addison TX 75001
• Manufacturer Contact: nicole conforti ; 4550 excel pkwy; ste 300; addison, TX 75001
• MDR Report Key: 15794571
• MDR Text Key: 305265635
• Report Number: 3009051471-2020-00012
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50-2000-001
• Device Lot Number: 607792
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1