MAUDE Adverse Event Report: CALDERA MEDICAL BENESTA TRD

Model Number CAL-TR1511

Device Problems Material Separation (1562); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 318015163
• Report Number: 3003990090-2023-01565
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 00857492008096
• UDI-Public: 00857492008096
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CAL-TR1511
• Device Catalogue Number: CAL-TR1511
• Device Lot Number: P01039
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female