MAUDE Adverse Event Report: COOPERSURGICAL, INC. HUMI- HARRIS UTERINE MANI

Model Number 6001

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2016

Event Type  malfunction  

Event Description

"tip broke inside patient." reference e-complaint number : (b)(4).

• Brand Name: HUMI- HARRIS UTERINE MANI
• Type of Device: HUMI- HARRIS UTERINE MANI
• Manufacturer (Section D): COOPERSURGICAL, INC.; 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: 5922534
• MDR Text Key: 223610862
• Report Number: 1216677-2016-00041
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K770727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/30/2018
• Device Model Number: 6001
• Device Catalogue Number: 600
• Device Lot Number: 187266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other