MAUDE Adverse Event Report: CLINICAL INNOVATIONS LLC CLEARVIEW UTERINE MANIPULATOR

Model Number	UM900
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
In the customers words: "thank you for returning my call earlier with regards to the above.As i mentioned this would be the second time this type of incident has happened on my watch within the last 2/3 years.The incidents are identical in that the spacer was left inside the vagina of both patients after the manipulator had been removed.The assumption is that the spacer is clicked into place but may dislodge with movement whilst being used therefore potentially left behind.Both patient had to go to a&e to have the foreign body removed.Unfortunately i do not have any lot numbers for any of the products as this is only noticed a few days after the procedure therefore product will already have been thrown away.The 1st i encountered this was at (b)(6) hospital and the product was either the um700 or um900.This time i am working at (b)(6) hospital and the product used was um900 as we only order the one product.Since we had this incident i would like to request some training for my staff as evidence for the patient that something has been done to prevent this from happening someone else.".
Additional Manufacturer Narrative
The device was not returned and no photos were provided.No lot number provided per risk-0006 rev.02, the complaint may be associated with the following potential failure mode: potential failure mode: user fails to remove the device from the cervical os.Potential effects: device fragments left in patient.Harms: foreign body in patient.Severity: 4.Potential cause: lack of attention, not qualified personnel.Probability of occurrence: 1.Risk is considered "monitor".No root cause can be determined.

• Brand Name: CLEARVIEW UTERINE MANIPULATOR
• Common Device Name: UTERINE MANIPULATOR
• 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: kellie stefaniak ; 747 w 4170 s; murray, UT 84123 ; 8012606079
• MDR Report Key: 14518226
• Report Number: 1722684-2022-00003
• Device Sequence Number: 5488574
• Product Code: LKF
• UDI-Device Identifier: 00814247020604
• UDI-Public: 00814247020604
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/26/2022

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: Health Professional
• Device Model Number: UM900
• Device Lot Number: UNKNOWN
• 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: 05/17/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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