MAUDE Adverse Event Report: CLINICAL INNOVATIONS CLEARVIEW UTERINE MANIPULATOR

Model Number	UM750
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and a follow-up will be submitted when the sample analysis is completed.This report being submitted since the reporter indicated an injury had occurred.The extent and nature of the reported injury has not been clarified.This has been requested from the initial reporter.
Event or Problem Description
This is a report on a health injury caused by your defective clearview total with no notch (a groove to fix the colpotomy cup tightly).The doctor tried to insert the device with the cup being insufficiently fixed into a patient and hurt her vaginal portion of cervix due to no sulcus fixation applied.
Additional Manufacturer Narrative
Device history record review: a dhr was performed and no ncr or deviation was found.Sample analysis: a visual inspection was performed on returned device and confirmed that the device does not have a notch to fix a colpotomy cup.The functionality test was performed on the returned device and found leakage from the tip of the balloon.Dissection of the balloon found a rolled stem in the balloon which cause the tip leak.The complaint is confirmed.In the investigation the production associated indicated that those devices may be the remaining clearview devices from the previous wip may have landed into a clearview total order.A functionality test was performed and found a leak at tip of the balloon.During the product evaluation found the cause of the failure was due to a dissection of the balloon which cause the tip leak.Root cause: a manufacturing error: the remaining um clearview devices were used from previous wip to um clearview total devices to order.The second issue identified rolling of the balloon stem on the dye injection tube from the needed interference fit of the two mating components.Conclusion: this complaint reported to fda because it was involved in injury with a patient.There is no other information provided.It is confirmed.Inspection on the manufacturing floor was performed and removed all devices from previous wip.Training was provided to the production associates and line leads on gmp.We continue to monitor and trend.

• Brand Name: CLEARVIEW UTERINE MANIPULATOR
• Common Device Name: CLEARVIEW UTERINE MANIPULATOR
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• MDR Report Key: 8606170
• Report Number: 1722684-2019-00005
• Device Sequence Number: 3030628
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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?: 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: 03/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other