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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE; HYSTEROSCOPE
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HOLOGIC, INC. MYOSURE; HYSTEROSCOPE Back to Search Results
Catalog Number 10-401
Device Problems Difficult to Remove (1528); Sticking (1597); Metal Shedding Debris (1804); Failure to Cut (2587)
Patient Problems Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)
Event Date 02/07/2014
Event Type  malfunction  
Event Description
The myosure device that was used first experienced a mechanical complication with resulting millimeter-sized segments of metal noted in the fibroid bed, which were subsequently resected.It has a rotating reciprocating cutting blade that dug into the distal end of the cutting window and became stuck.The blade emerged about 50% out of the cutting window so that the device could not be removed from the hysteroscope.The myosure that was used second looks normal but apparently also did not adequately cut and remove tissue.They subsequently switched to a bipolar resectoscope to finish the case.
 
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Brand Name
MYOSURE
Type of Device
HYSTEROSCOPE
Manufacturer (Section D)
HOLOGIC, INC.
35 crosby drive
bedford MA 01730
MDR Report Key3888113
MDR Text Key4424879
Report Number3888113
Device Sequence Number1
Product Code HIH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 06/03/2014
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 Physician
Device Catalogue Number10-401
Device Lot Number13J17R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2014
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/03/2014
Event Location Hospital
Date Report to Manufacturer06/23/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/03/2014
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
Patient Age46 YR
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