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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL DEVICE
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HOLOGIC MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL DEVICE Back to Search Results
Catalog Number 10-401
Device Problem Component Falling (1105)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/19/2015
Event Type  malfunction  
Event Description
It was reported that a physician performed a myosure procedure for uterine tissue removal on (b)(6) 2015.During the procedure a "small piece of the coating on the tip of the probe fell into the surgical site".The tip was removed and the procedure was completed.The pt was discharged home.
 
Manufacturer Narrative
Device history record (dhr) review was conducted for the reported lot number.The lot was released meeting all qa specs.Currently unable to establish a relationship or impact to the reported observation.Reference internal complaint cc#(b)(4).
 
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Brand Name
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Type of Device
UTERINE TISSUE REMOVAL DEVICE
Manufacturer (Section D)
HOLOGIC
marlborough MA
Manufacturer Contact
craig callahan
250 campus drive
marlborough, MA 01752
5082638859
MDR Report Key4862942
MDR Text Key5844885
Report Number1222780-2015-00109
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/19/2015
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 Expiration Date02/18/2018
Device Catalogue Number10-401
Device Lot Number15C14R
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/03/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/15/2015
Initial Date FDA Received06/19/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MYOSURE HYSTEROSCOPE - SERIAL# UNK,; CONTROL UNIT - SERIAL# UNK,; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
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