MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC COMPLETE CLEAR VIEW TOTAL KIT; UTERINE MANIPULATOR

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 05/01/2017

Event Type  malfunction  

Event Description

Trail product name complete clear view total kit, used for uterine manipulator.Loose piece that shouldn't have been loose broke off in patient.

• Brand Name: COMPLETE CLEAR VIEW TOTAL KIT
• Type of Device: UTERINE MANIPULATOR
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC
• MDR Report Key: 6717783
• MDR Text Key: 80315159
• Report Number: MW5071017
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR