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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC MYOSURE ROD LENS HYSTEROSCOPE
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HOLOGIC MYOSURE ROD LENS HYSTEROSCOPE Back to Search Results
Catalog Number 40-250
Device Problem Noise, Audible (3273)
Patient Problems Perforation (2001); Hypovolemia (2243)
Event Date 03/09/2015
Event Type  Injury  
Event Description
It was reported that prior to a scheduled novasure endometrial ablation on (b)(6) 2015, the physician inserted a myosure hysteroscope and "heard a pop and the fluid deficit immediately started to climb".The physician perforated the "uterine canal".The procedure was aborted.It is unk if intervention was required.
 
Manufacturer Narrative
The 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 prod identification numbers were not provided by the complainant.According to the instructions for use (ifu) warnings: uterine perforation can result in possible injury to bowel, bladder, major blood vessels, and ureter.(b)(4).
 
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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 Key4694050
MDR Text Key5713074
Report Number1222780-2015-00061
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 03/09/2015
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 Health Professional
Device Catalogue Number40-250
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/09/2015
Initial Date FDA Received04/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
MYOSURE TRD - LOT# UNK; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYS CONTROL,; UNIT-SERIAL#UNK
Patient Outcome(s) Other;
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