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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC MYOSURE; HYSTEROSCOPE AND ACCESSORIES
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HOLOGIC MYOSURE; HYSTEROSCOPE AND ACCESSORIES Back to Search Results
Model Number 10-401
Device Problem Failure to Shut Off (2939)
Patient Problem No Information (3190)
Event Date 11/11/2015
Event Type  malfunction  
Event Description
The myosure device was placed within the uterine cavity and the fibroid/polyp was removed with slow tedious dissection.When the physician removed her foot from the foot pedal, the myosure device kept running.The physician had to hit the pedal two or three times to make it stop.The operating personnel call the manufacturer's representative, who said it was either the pedal or the device.The operating room personnel removed the device.Another myosure device was brought in to complete the procedure.The myosure scope was then removed from the uterine cavity.The patient was taken to the recovery room breathing on her own in excellent condition.
 
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Brand Name
MYOSURE
Type of Device
HYSTEROSCOPE AND ACCESSORIES
Manufacturer (Section D)
HOLOGIC
250 campus drive
marlborough MA 01752
MDR Report Key5260124
MDR Text Key32507529
Report Number5260124
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 11/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date06/30/2018
Device Model Number10-401
Device Lot Number15G14RB
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2015
Event Location Hospital
Date Report to Manufacturer11/18/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/02/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age55 YR
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