MAUDE Adverse Event Report: CALDERA MEDICAL DESARA TVEZ3.0

Model Number CAL-DS01BTV30

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 04/13/2023

Event Type  malfunction  

Event Description

During a procedure using desara tvez3.0, the wire came loose as the surgeon was passing through the anatomical path.There were no injuries to the patient.

• Brand Name: DESARA TVEZ3.0
• Type of Device: DESARA TVEZ3.0
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361
• Manufacturer Contact: ryan troncoso
• MDR Report Key: 16964362
• MDR Text Key: 315963052
• Report Number: 3003990090-2023-01562
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00890594000124
• UDI-Public: 00890594000124
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CAL-DS01BTV30
• Device Catalogue Number: CAL-DS01BTV30
• Device Lot Number: N09064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female