MAUDE Adverse Event Report: COOPERSURGICAL KRONNER MANIPUJECTOR

Model Number 6003

Device Problems Break (1069); Detachment Of Device Component (1104); Material Protrusion/Extrusion (2979)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical is currently investigating the reported complaint condition.The affected device is not being returned for investigation.Once the investigation is complete a follow-up report will be filed.

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.

Manufacturer Narrative

The affected device for the reported event of the tip breaking off during the procedure cannot be verified or analyzed as it will not be returned to coopersurgical.The affected lot was reported as "unknown" therefore a dhr history review cannot be performed.However, if the affected device is returned in the future, the complaint may be reopened and addressed as needed.Root cause is considered indeterminable as the affected device will not be returned for physical investigative analysis and verification.Review of past similar complaints for this product family determined that the most likely cause was attributed to improper use or mishandling of the device contrary to the dfu instructions for use.

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 MANIPUJECTOR
• Type of Device: KRONNER
• Manufacturer (Section D): COOPERSURGICAL; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 7061065
• MDR Text Key: 93484965
• Report Number: 1216677-2017-00071
• Device Sequence Number: 1
• Product Code: HES
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 6003
• Device Catalogue Number: 6003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR