MAUDE Adverse Event Report: COOPER SURGICAL, INC. KRONNER (MANIPULATOR); INSUFFLATOR, CARBON DIOXIDE UTEROTUBAL

Model Number 6003

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2017

Event Type  Injury  

Event Description

The kronner has a tip with a balloon and once inserted through the cervix, the balloon is inflated and the handle protrudes from the vagina.The tip was inserted and during the procedure broke off from the handle and was inside the uterus.Broken piece needed to be retrieved by hysteroscopy.

• Brand Name: KRONNER (MANIPULATOR)
• Type of Device: INSUFFLATOR, CARBON DIOXIDE UTEROTUBAL
• Manufacturer (Section D): COOPER SURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• MDR Report Key: 7048309
• MDR Text Key: 92643500
• Report Number: MW5073431
• Device Sequence Number: 1
• Product Code: HES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR