MAUDE Adverse Event Report: CLINICAL INNOVATIONS, INC. CLEARVIEW UTERINE MANIPULATOR; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number UM700

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2020

Event Type  malfunction  

Event Description

Retained foreign object.The small cap/spacer that is a part of the clear view uterine manipulator that is used in gyn surgeries came loose and was found 2 weeks later, at the post-op checkup, in the patient's vagina.Fda safety report id# (b)(4).

• Brand Name: CLEARVIEW UTERINE MANIPULATOR
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CLINICAL INNOVATIONS, INC. ; murray UT 84123
• MDR Report Key: 10448581
• MDR Text Key: 204414644
• Report Number: MW5096241
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2022
• Device Model Number: UM700
• Device Lot Number: 192294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR