MAUDE Adverse Event Report: CALDERA MEDICAL INC. DESARA BLUE TV; No Match

Catalog Number	CAL-DSO1BTV
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint details: surgeon reported that while pulling the dilator tubes up above the pubic bone, the tube detached from the plastic sheath.Complaint investigation: reviewed the lot history file for lot #q05055.The file includes results from a junction strenght test, which measures the break force between the dilator tube and the mesh sleeve.The acceptance criterion for this test ia minimum break force of 6.3 pound-force (lbf).All tested units passed, with results ranging from 13.8 lbf to 22.3 lbf.Additionally, a mesh strengh test was performed, which measures the break force of the mesh alone (with no sleeve attached).The acceptance criterion for this test is a minimum of 6.5 lbf.All tested units met this requirement, with results ranging from 13.5 lbf to 19.9 lbf.Investigation assesment is that the tube may have been pulled with excessive force.
Event or Problem Description
Surgeon reported while pulling the dilator tubes up above the pubic bone, the tube detached from the plastic sheath.

• Brand Name: DESARA BLUE TV
• Common Device Name: No Match
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace drive; westlake village CA 91361
• Manufacturer (Section G): CALDERA MEDICAL INC.; 4360 park terrace drive; westlake village CA 91361
• Manufacturer Contact: sergio rodriguez ; 4360 park terrace drive; westlake village, CA 91361 ; 8188796555
• MDR Report Key: 22583288
• Report Number: 3003990090-2025-01599
• Device Sequence Number: 11884360
• Product Code: OTN
• UDI-Device Identifier: 00890594000834
• UDI-Public: 00890594000834
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CAL-DSO1BTV
• Device Lot Number: Q05055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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