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	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow up will be submitted when investigation is complete.
Event or Problem Description
Before use, there is no groove for fixing the colpotomy cup.
Additional Manufacturer Narrative
Device history lot review: dhr review was performed on lot #181183.No ncr or deviation was found.Sample analysis: no sample was returned for the product evaluation.Conclusion: the complaint is not confirmed.If a sample is received, a supplemental report will be reported.At this time, since no sample has been received the complaint is not confirmed.This complaint has now been closed.
Additional Manufacturer Narrative
Device history lot review: dhr review was performed on lot #181183.No ncr or deviation was found.We have received the sample.Sample analysis: a visual inspection was performed on the returned device and confirmed no signs of damage/broken was found on the device.But the device does not have a notch to fix the colpotomy cup.The customer complaint was confirmed.To confirm the functionality of the device, testing was performed and passed.In the investigation the production associates indicated that the device may be the remaining clearview devices from the previous wip and many have landed in a clearview total order.Inspection of the manufacturing floor was performed and removed all devices from wip.Training was provided to clearview production associates and line leads on good manufacturing practices included that wip from previous orders many not be stored for use on future orders.This failure mode will be monitored and trended.This complaint is now closed.

• 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: 8617037
• Report Number: 1722684-2019-00009
• Device Sequence Number: 14018109
• 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,Followup
• Report Date (Section B): 07/16/2019

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 Expiration Date: 09/14/2020
• Device Model Number: UM750
• Device Lot Number: 181183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 06/14/2019; 07/16/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/14/2019; 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1