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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZINNANTI UTERINE MANIPULATOR; CANNULA, MANIPULATOR, INJECTOR, UTERINE

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ZINNANTI UTERINE MANIPULATOR; CANNULA, MANIPULATOR, INJECTOR, UTERINE Back to Search Results
Model Number 2372
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 07/12/2017
Event Type  malfunction  
Event Description
Pt was seen for a post operative visit (b)(6) 2017 and on pelvic exam a piece of the uterine manipulator was removed from her vagina.
 
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Brand Name
ZINNANTI UTERINE MANIPULATOR
Type of Device
CANNULA, MANIPULATOR, INJECTOR, UTERINE
MDR Report Key6809685
MDR Text Key83466574
Report NumberMW5071731
Device Sequence Number1
Product Code LKF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2372
Device Catalogue NumberTM1151-MPM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/22/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age35 YR
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