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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION VCARE; CANNULA, MANIPULATOR/INJECTOR, UTERINE

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CONMED CORPORATION VCARE; CANNULA, MANIPULATOR/INJECTOR, UTERINE Back to Search Results
Model Number 606085202A
Device Problems Inflation Problem (1310); Material Puncture/Hole (1504); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 11/23/2020
Event Type  malfunction  
Event Description
The uterine manipulator used was defective and the balloon was perforated and failed to inflate.Fda safety report id# (b)(4).
 
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Brand Name
VCARE
Type of Device
CANNULA, MANIPULATOR/INJECTOR, UTERINE
Manufacturer (Section D)
CONMED CORPORATION
MDR Report Key10975735
MDR Text Key220691670
Report NumberMW5098262
Device Sequence Number1
Product Code LKF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number606085202A
Device Lot Number202009211
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient Age51 YR
Patient Weight93
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