MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC CLEARVIEW UTERINE MANIPULATOR

Catalog Number	UM900
Medical Device Problem Codes	Overfill (2404); Human Factors Issue (2948)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	04/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our ifu 050-0709 rev.B clearly differentiates between the two lumens and indicates what volume is required to inflate the balloon.
Event or Problem Description
During a surgery the tubes should be flushed to evaluate if one or two tubes should be removed.The clear view is inserted into the uterus and to keep it there 2-3 ml salted water is infused to fill a small balloon.There are two tubes one to fill the balloon and one for injection of contrast fluid.During the operation the contrast fluid was connected to the wrong tube and the balloon inside the uterus was inflated further and the pressure in the uterus became so high, that the uterus blew in the top of uterus.The consequence of the incidence is that the patience is not recommended to perform a vaginal birth as the risk of rupture of uterus is high during birth.Besides that it is not recommended to get pregnant for the next 3 months which is a burden as the patient already is a fertility patient.

• Brand Name: CLEARVIEW UTERINE MANIPULATOR
• Common Device Name: UTERINE MANIPULATOR
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 6186487
• Report Number: 1722684-2016-00004
• Device Sequence Number: 19089436
• Product Code: LKF
• UDI-Device Identifier: 00814247020604
• UDI-Public: 00814247020604
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K940681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring,Replace
• Type of Report: Initial
• Report Date (Section B): 12/17/2016

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 Expiration Date: 12/01/2017
• Device Catalogue Number: UM900
• Device Lot Number: 151295
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2016
• Initial Report FDA Received Date: 12/19/2016
• 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: Hospitalization; Disability