MAUDE Adverse Event Report: CALDERA MEDICAL, INC DESARA BLUE TVEZ 3.0 SYSTEM; SUI SLING AND TROCAR

Model Number	CAL-DS01BTV30
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to a surgical procedure to implant a desara mesh in a patient, the instrument wire component detached from its handle.The wire broke loose, resulting in the wire spinning freely within the handle and eventually coming out completely from the handle.There was no patient injury.No further information were reported.Based on the complaint information provided, it is unconclusive if the event is related to the device, surgical approach, surgeon experience, and/or patient anatomy.Device history records were reviewed and device met all acceptance criteria.This report is filed pursuant to 21 cfr 803 and all information contained within this report is subject to the details provided by the reporter.Any subsequent information will be provided in a follow-up report.

• Brand Name: DESARA BLUE TVEZ 3.0 SYSTEM
• Common Device Name: SUI SLING AND TROCAR
• Manufacturer (Section D): CALDERA MEDICAL, INC; 4360 park terrace drive; suite 140; westlake village CA 91361
• Manufacturer (Section G): CALDERA MEDICAL, INC; 4360 park terrace drive; suite 140; westlake village CA 91361
• Manufacturer Contact: vicki gail ; 4360 park terrace drive; suite 140; westlake village, CA 91361 ; 8188796555
• MDR Report Key: 20854855
• Report Number: 3003990090-2024-01577
• Device Sequence Number: 8574206
• Product Code: PWJ
• UDI-Device Identifier: 00890594000124
• UDI-Public: 00890594000124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2026
• Device Model Number: CAL-DS01BTV30
• Device Lot Number: P05037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• Is the Device Labeled for Single Use? (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: Other
• Patient Sex: Female