MAUDE Adverse Event Report: CALDERA MEDICAL INC. DESARA BLUE TV; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE,

Catalog Number	CAL-DSO1BTV
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Similarities between the component tip protectors and caldera'a heat-shrink tubing make investigation findings inconclusive.
Event or Problem Description
The patient with a complex medical history including a single kidney, abdominal adhesions, sacrocolpopexy, and pelvic organ prolapse, underwent both robotic-assisted and traditional surgery.At the six-week post-op follow-up, recovery appeared normal.However, by the ten-week mark, the patient reported localized pain at the left supra-pubic incision site, where 3/4 to 1 inch clear plastic tube-like object emerged, possibly from an infection.The patient initially identified the pain as originating from the supra-pubic incision but later revised the assesment, attributing it to a robotic incision site.The surgeon and one closely monitored attending were present at the case.Photographs showed the incision as closed and healing.Dr.Lind recommended identifying all 50 components used in the robotic system, noting the expelled object resembled a tip protector used robotic-assisted surgery similar to caldera medical's heat-shrink tubing.Despite the complication, the overall surgical outcome was positive.

• Brand Name: DESARA BLUE TV
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE,
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace; westlake village CA 91361
• Manufacturer Contact: sergio rodriguez ; 4360 park terrace; westlake village, CA 91361 ; 8188796555
• MDR Report Key: 22561859
• Report Number: 3003990092-0250-01597
• Device Sequence Number: 9219756
• Product Code: OTN
• UDI-Device Identifier: 00890594000834
• UDI-Public: 00890594000834
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/21/2025

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
• Device Catalogue Number: CAL-DSO1BTV
• Device Lot Number: UNKNOWN
• 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: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 45 KG