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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; ENDOSCOPIC CYTOLOGY BRUSH
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; ENDOSCOPIC CYTOLOGY BRUSH Back to Search Results
Lot Number 24592135
Device Problem Difficult or Delayed Separation (4044)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2020
Event Type  malfunction  
Event Description
During bronchoscopy cytology brush was opened- scrub tech noted the brush did not deploy properly from the sheath.
 
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Type of Device
ENDOSCOPIC CYTOLOGY BRUSH
MDR Report Key10559699
MDR Text Key207726522
Report Number10559699
Device Sequence Number1
Product Code FDX
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 09/10/2020
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 Lot Number24592135
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/10/2020
Event Location Hospital
Date Report to Manufacturer09/21/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/21/2020
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age26645 DA
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