MAUDE Adverse Event Report: COOPERSURGICAL, INC THE KOH COLPOTOMIZER SYSTEM; KC-RUMI

Device Problem Malposition of Device (2616)

Patient Problems Abnormal Vaginal Discharge (2123); Foreign Body In Patient (2687)

Event Date 06/28/2014

Event Type  malfunction  

Event Description

Maude event report# (b)(4).

Manufacturer Narrative

(b)(4).Coopersurgical inc is currently investigating the reported complaint condition.A final report will be filed after customer follow up and the investigation is complete.

• Brand Name: THE KOH COLPOTOMIZER SYSTEM
• Type of Device: KC-RUMI
• Manufacturer (Section D): COOPERSURGICAL, INC; trumbull CT
• Manufacturer Contact: nan banafo ; 75 corporate dr; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 4219157
• MDR Text Key: 16182898
• Report Number: 1627186-2014-00011
• Device Sequence Number: 1
• Product Code: KOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention