MAUDE Adverse Event Report: CALDERA MEDICAL INC. DESARABLUE TV EZ 3.0 CAL-DSB01TV30; DESERA BLUE

Model Number	CAL-DS01BTV30
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d5, h3, h6, h11.Investigation results: the investigation found that the device itself met all manufacturing and quality specifications, with the device history record showing no nonconformities.A cross-functional review suggested that resistance during sling advancement, possibly combined with the trocar not being fully seated or improper device loading, led to the puncture.The report concludes that the primary contributing factor was user error related to surgical technique and excessive force during device advancement.Given these findings, no immediate corrective and preventive actions (capa) are proposed, and the complaint will continue to be monitored through routine post-market surveillance.The investigation will be re-evaluated if new information arises.The manufacturing number is (b)(4).
Additional Manufacturer Narrative
The investigation is ongoing, and the results will be reported.The manufacturing number is c25-2875.
Event or Problem Description
It was reported that the surgeon advanced the sling through the patient as usual, and the trocar came through just at the end of the blue dilator tube.The outcome of the surgery was successful; another sling was opened, and the procedure was completed successfully.

• Brand Name: DESARABLUE TV EZ 3.0 CAL-DSB01TV30
• Common Device Name: DESERA BLUE
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr.; suite 140; westlake village CA 91361
• Manufacturer (Section G): CALDER MEDICAL SARL-NAUCHATEL; puits-godet 20; neuchatel, 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr. suite 140; westlake village, CA 91361
• MDR Report Key: 23406039
• Report Number: 3003990090-2025-01687
• Device Sequence Number: 14687487
• Product Code: PWJ
• UDI-Device Identifier: 00890594000124
• UDI-Public: 00890594000124
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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 Model Number: CAL-DS01BTV30
• Device Catalogue Number: CAL-DS01TV30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Female