MAUDE Adverse Event Report: CLINICAL INNOVATIONS CLEARVIEW TOTAL UTERINE MANIPULATOR

Model Number	UM750
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample has been received.Follow up will be submitted when investigation is complete.
Event or Problem Description
No groove to attach the colpotomy cup.Our qa people checked all clearview total devices and found 1 that had exactly the same problem that we reported last week.This device was stored in the warehouse.
Additional Manufacturer Narrative
Device history lot review: no ncrs or deviations.The lot met specifications outlined for release sample analysis: visual inspection verified the reported failure of no grooves for attachment of the colpotomy cups.Investigation: it has been determined that the cause is most likely an assembly error and the wrong component was used to make the um750 devices.Only a few devices of this lot seem to be manufactured wrong.Actions: at this time this failure is limited to this lot and are the first of its type historically.Complaints will be monitored and if further failures are found further investigation will be performed to determine potential corrective action.This device sample was stored in the warehouse at the complainant site and all devices were inspected.This was incident was detected prior to the device being shipped to a user facility.Conclusion: the complaint is confirmed.

• Brand Name: CLEARVIEW TOTAL UTERINE MANIPULATOR
• Common Device Name: CLEARVIEW TOTAL UTERINE MANIPULATOR
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• MDR Report Key: 8616917
• Report Number: 1722684-2019-00006
• Device Sequence Number: 16673591
• Product Code: LKF
• UDI-Device Identifier: 00814247020499
• UDI-Public: 00814247020499
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K940681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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: Health Professional
• Device Model Number: UM750
• Device Lot Number: 181183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1