MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC CLEARVIEW UTERINE MANIPULATOR; MANIPULATOR/INJECTOR, UTERINE

Model Number	UM700
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Clinical innovations is gathering more information regarding this incident.If additional information is obtained, a follow-up will be provided.
Event or Problem Description
On (b)(6) 2019 a patient had an abdominal myomectomy in which a clearview uterine manipulator (ref#um700) was used.Sometime during case the white tip of the uterine manipulator came off and remained inside the patient.No one noticed that the tip had come off and remained in the patient during surgery.It was not until later in the day when the patient was using the bathroom and the tip was expelled that the realization of the retained tip was discovered.The hand piece was not saved.Nor was the serial number recorded.

• Brand Name: CLEARVIEW UTERINE MANIPULATOR
• Common Device Name: MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 9587744
• Report Number: 1722684-2020-00003
• Device Sequence Number: 17057531
• Product Code: LKF
• UDI-Device Identifier: 00814247020017
• UDI-Public: 00814247020017
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K940681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

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
• Operator of Device: No Information
• Device Model Number: UM700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other