MAUDE Adverse Event Report: CALDERA MEDICAL BENESTA TRD

Model Number	CAL-TR1511
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Trd outer cutter detached from device during the procedure.Second trd was used and procedure was completed.Caldera rep noticed the outer cutter was bent during the procedure, caused by torquing the device while inside the working channel of the hysteroscope.

• Brand Name: BENESTA TRD
• Common Device Name: BENESTA TRD
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace drive; westlake village CA 91361
• Manufacturer Contact: ryan troncoso ; 4360 park terrace drive; westlake village, CA 91361
• MDR Report Key: 17167295
• Report Number: 3003990090-2023-01565
• Device Sequence Number: 17596866
• Product Code: HIH
• UDI-Device Identifier: 00857492008096
• UDI-Public: 00857492008096
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2023

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
• Device Expiration Date: 07/01/2024
• Device Model Number: CAL-TR1511
• Device Catalogue Number: CAL-TR1511
• Device Lot Number: P01039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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