Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC MYOSURE ROD LENS HYSTEROSCOPE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HOLOGIC MYOSURE ROD LENS HYSTEROSCOPE Back to Search Results
Catalog Number 40-250
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vaso-Vagal Response (2661)
Event Date 03/18/2014
Event Type  Injury  
Event Description
It was reported that during a myosure procedure for uterine tissue removal, the physician had difficulty inserting the hysteroscope past the internal os.The fluid deficit reached 900ml when a second scope was inserted and the pt experienced a seizure.The physician removed the scope and aborted the procedure.The pt was stable and no intervention was required.
 
Manufacturer Narrative
Myosure hysteroscope is not being returned therefore, a failure analysis of the myosure hysteroscope can not be completed.Device history record (dhr): review was not able to be conducted for the myosure hysteroscope as product identification numbers were not provided by the complainant.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MYOSURE ROD LENS HYSTEROSCOPE
Type of Device
HYSTEROSCOPE
Manufacturer (Section D)
HOLOGIC
marlborough MA
Manufacturer Contact
craig callahan
250 campus drive
marlborough, MA 01752
5082638859
MDR Report Key3786860
MDR Text Key4443208
Report Number1222780-2014-00062
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091465
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 03/18/2014
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 Health Professional
Device Catalogue Number40-250
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date03/18/2014
Initial Date Manufacturer Received 03/18/2014
Initial Date FDA Received04/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CONTROL UNIT - SERIAL NUMBER UNK; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Patient Outcome(s) Other;
-
-