MAUDE Adverse Event Report: CALDERA MEDICAL DESARA BLUE TVEZ 2.7; MESH SLING

Model Number	CAL-DS01BTV27
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a trial of desara tvez 2.7, the physician encoutered some resistance in the patients abdomen.He retracted the instrument slightly in order to make a puncture incision and then repassed the instrument.At this point, the surgeon realized that the dilator tube was no longer on the trocar.Upon widthdrawing the instrument, it was identified that the trocar had broken through and damaged the dilator tube.The procedure was completed with our desara blue tv device without issue.
Additional Manufacturer Narrative
It was determined that when the surgeon retracted the instrument, the trocar and dilator tube separated, likely due to the dilator tube being stuck in scar tissue.When the surgeon attempted to repass the instrument, the tip of the trocar was not aligned with the dilator tube, and broke through the side wall.A design control project was initiated in order to evaluate and update the device in order to prevent recurrence of the issue.

• Brand Name: DESARA BLUE TVEZ 2.7
• Common Device Name: MESH SLING
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361
• Manufacturer (Section G): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361
• Manufacturer Contact: alicia heckathorne ; 4360 park terrace drive; westlake village, CA 91361 ; 8184837626
• MDR Report Key: 14275013
• Report Number: 3003990090-2021-01535
• Device Sequence Number: 20073946
• Product Code: OTN
• UDI-Device Identifier: 00890594000193
• UDI-Public: 00890594000193
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 05/02/2022

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-DS01BTV27
• Device Lot Number: M09020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2021
• 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