MAUDE Adverse Event Report: CALDERA MEDICAL BENESTA; BENESTA TRD

Catalog Number CAL-TR1511

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 07/11/2023

Event Type  malfunction  

Event Description

The outer sheath came off prior to inserting the trd into the hysteroscope.

• Brand Name: BENESTA
• 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: 18116130
• MDR Text Key: 327905830
• Report Number: 3003990090-2023-01568
• 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: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CAL-TR1511
• Device Lot Number: P02014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2023
• 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 Outcome(s): Hospitalization
• Patient Sex: Female