MAUDE Adverse Event Report: CALDERA MEDICAL DESARA TVEZ3.0

Model Number	CAL-DS01BTV30
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: DESARA TVEZ3.0
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361
• Manufacturer Contact: ryan troncoso
• MDR Report Key: 16964362
• Report Number: 3003990090-2023-01562
• Device Sequence Number: 5238427
• Product Code: OTN
• UDI-Device Identifier: 00890594000124
• UDI-Public: 00890594000124
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/27/2024
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female