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

Model Number	UM950
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are working with the initial reporter to obtain more details and device information.If more information is obtained, a follow-up report may be submitted.
Event or Problem Description
After the product was inserted into the patient, the tip of the bending part became stuck after a short period of operation.After removing the product from the patient, the doctor found that the gear part of the bending part was damaged.At this time, a cervical laceration occurred.The product was replaced immediately, but the operation was delayed by 5 minutes.

• Brand Name: CLEARVIEW UTERINE MANIPULATOR
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• 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: 20612479
• Report Number: 1722684-2024-00014
• Device Sequence Number: 8144367
• Product Code: LKF
• UDI-Device Identifier: 00814247020611
• UDI-Public: 00814247020611
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K131781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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: UM950
• Device Lot Number: 231013
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown