MAUDE Adverse Event Report: CLINICAL INNOVATIONS LLC CLEARVIEW UTERINE MANIPULATOR; UTERINE MANUIPULATOR

Model Number	UM700
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After receiving the event, an investigation has been opened to look further into the details.A follow-up report may be submitted if more details are received from what is currently reported in this event.
Event or Problem Description
On (b)(6) 2024, the clearview uterine manipulator was used in a surgical procedure.On june 25, 2024, the patient notified her physician that small, pliable, white particles were coming from her vagina.On june 26, 2024, the patient returned to the physician's office and presented small, soft, rubbery white particles in a baggie.

• Brand Name: CLEARVIEW UTERINE MANIPULATOR
• Common Device Name: UTERINE MANUIPULATOR
• Manufacturer (Section D): CLINICAL INNOVATIONS LLC; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS LLC; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: thomas hirte ; 747 w 4170 s; murray, UT 84123 ; 8012688200
• MDR Report Key: 19778948
• Report Number: 1722684-2024-00011
• Device Sequence Number: 20939721
• Product Code: LKF
• UDI-Device Identifier: 00814247020017
• UDI-Public: 00814247020017
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/18/2024

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: Health Professional
• Device Model Number: UM700
• Device Lot Number: 231412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female