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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE REACH; HYSTEROSCOPE (AND ACCESSORIES)
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HOLOGIC, INC. MYOSURE REACH; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Lot Number 19H01RH
Device Problems Loss of Power (1475); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/09/2019
Event Type  malfunction  
Event Description
When myosure reach handpiece was connected to the myosure box, myosure reach handpiece (lot# 19h01rh) was shaking abnormally and the timing display on the myosure box turned off and would not turn back on.It did not operate, was not used for the patient, and removed from the surgical field.Another myosure box was brought into the room and connected to the same myosure reach handpiece (lot# 19h01rh) to test.It was not operating but shaking roughly.The circulating nurse was trying to remove the handpiece out of the myosure box, the handpiece was stuck and could not be removed.Clinical engineering staff removed the stuck handpiece.The myosure box was operating normally with other handpieces.
 
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Brand Name
MYOSURE REACH
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
HOLOGIC, INC.
445 simarano drive
marlboro MA 01752
MDR Report Key9362537
MDR Text Key167599387
Report Number9362537
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number19H01RH
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/30/2019
Event Location Hospital
Date Report to Manufacturer11/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age12775 DA
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