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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. N/A; HYSTEROSCOPE (AND ACCESSORIES)
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HOLOGIC, INC. N/A; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Model Number N/A
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/17/2023
Event Type  malfunction  
Event Description
Opened the package per md and then plugged myosure reach into the myosure.When the doctor placed the instrument into the patient and activated the instrument the device itself started to shake when operating.The doctor was not able to reach the polyp with the instrument and the doctor wanted to open a new myosure reach.No obvious injury was reported at the time that the exchange was made.Per the nurse, the device "started shaking" when the doctor activated the myosure.The procedure was stopped, the device removed and a new myosure was used.The device was sequestered and given to someone in supply chain.No injury to the patient.Manufacturer response for myosure reach, myosure reach (per site reporter).
 
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Brand Name
N/A
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
HOLOGIC, INC.
445 simarano drive
marlborough MA 01752
MDR Report Key16843175
MDR Text Key314272273
Report Number16843175
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 04/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberN/A
Device Catalogue Number10-401FC
Device Lot Number23A20RA
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/26/2023
Date Report to Manufacturer05/01/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age17885 DA
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