MAUDE Adverse Event Report: CLINICAL INNOVATIONS CLEARVIEW UTERINE MANIPULATOR

Model Number	UM700
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported "i am e-mailing with regards to your clearview uterine manipulator, with the 7cm blunt tip (ref: um700).We have had an event over the weekend with regards to a patient having retained a part of the manipulator and then they passed this.The item was the spacer that comes separately from the manipulator, in the box.".

• Brand Name: CLEARVIEW UTERINE MANIPULATOR
• Common Device Name: UTERINE MANIPULATOR
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: kellie stefaniak ; 747 w 4170 s; murray, UT 84123 ; 8015169243
• MDR Report Key: 13426408
• Report Number: 1722684-2022-00001
• Device Sequence Number: 14406128
• Product Code: LKF
• UDI-Device Identifier: 00814247020017
• UDI-Public: 00814247020017
• Combination Product (Y/N): N
• PMA/510(K) Number: K940681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 09/02/2023
• Device Model Number: UM700
• Device Lot Number: 214486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown