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

Model Number 6001

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted retrospectively per fda request.

Event Description

"the tip broke inside the pt" "the item was too bloody to be sent per operating room" for return evaluation.Reference: (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: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 8028238
• MDR Text Key: 313671142
• Report Number: 1216677-2018-00033
• 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,Followup
• Report Date: 04/20/2023

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: 07/21/2020
• Device Model Number: 6001
• Device Catalogue Number: 6001
• Device Lot Number: 226175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2017
• 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