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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE XL; HYSTEROSCOPE, ACCESSORIES

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HOLOGIC, INC. MYOSURE XL; HYSTEROSCOPE, ACCESSORIES Back to Search Results
Model Number 50-501XL
Device Problems Device Stops Intermittently (1599); Difficult to Open or Close (2921)
Patient Problem No Information (3190)
Event Date 12/13/2016
Event Type  malfunction  
Event Description
The tip does not close all the way and device would only work for three seconds and stopped when on continuous pressure.
 
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Brand Name
MYOSURE XL
Type of Device
HYSTEROSCOPE, ACCESSORIES
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
MDR Report Key6213203
MDR Text Key63535472
Report Number6213203
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/13/2016
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 No Information
Device Model Number50-501XL
Device Lot Number15F24RD
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/13/2016
Event Location Hospital
Date Report to Manufacturer12/13/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age31 YR
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