MAUDE Adverse Event Report: COOPERSURGICAL, INC. KRONNER MANIPUJECTOR - UTERINE MANIPULATOR-INJECTOR ; INSUFFLATOR, CARBON-DIOXIDE UTEROTUBAL (AND ACCESSORIES)

Model Number 6003

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 08/06/2019

Event Type  malfunction  

Event Description

Portion of catheter broke off and retained in uterus.Not noted catheter broke during surgery.Pt reported catheter fell out of vagina at home.

• Brand Name: KRONNER MANIPUJECTOR - UTERINE MANIPULATOR-INJECTOR
• Type of Device: INSUFFLATOR, CARBON-DIOXIDE UTEROTUBAL (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC. ; 95 corporate dr. ; trumbull CT 06611
• MDR Report Key: 9677012
• MDR Text Key: 178214511
• Report Number: MW5092809
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6003
• Device Catalogue Number: 6003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 39