MAUDE Adverse Event Report: COOPER SURGICAL KRONNER MANIPUJECTOR (HUMI); INSUFFLATOR

Model Number 6003

Device Problem Device Inoperable (1663)

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

Event Date 11/07/2014

Event Type  Injury  

Event Description

Kronner manipujector (humi) was tested by surgery tech prior to use on back table.Placed in uterus and balloon inflated.Once tubal ligation procedure was started, surgeon noted that uterus was not moving correctly.Humi was withdrawn from uterus and it was noted that the balloon was not working.

• Brand Name: KRONNER MANIPUJECTOR (HUMI)
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): COOPER SURGICAL; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 4280350
• MDR Text Key: 5228059
• Report Number: MW5039264
• Device Sequence Number: 1
• Product Code: HES
• 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: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 6003
• Device Lot Number: 167547
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR