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

Catalog Number UM700

Device Problem Inflation Problem (1310)

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

Event Date 04/24/2015

Event Type  malfunction  

Event Description

Surgeon tested uterine manipulator before using and discovered the balloon would not inflate.This device was handed off of sterile field and another uterine manipulator opened.The new one worked without any issues.
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manufacturer response for uterine manipulator, (brand not provided) (per site reporter).
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unknown by reporter.Sales rep notified.

• Brand Name: CLEARVIEW UTERINE MANIPULATOR
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CLINICAL INNOVATIONS LLC; 747 west 4170 south; murray UT 84123
• MDR Report Key: 4764681
• MDR Text Key: 18886607
• Report Number: 4764681
• Device Sequence Number: 1
• Product Code: LKF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: UM700
• Device Lot Number: 131173
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2015
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 62