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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION DISPOSABLE GASTROINTESTINAL CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH
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CONMED CORPORATION DISPOSABLE GASTROINTESTINAL CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH Back to Search Results
Model Number 158R
Device Problems Break (1069); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/21/2019
Event Type  malfunction  
Event Description
During upper endoscopy, rn attempted to brush patient's esophagus lining with cytology brush.As the rn tried to push the brush out, it was difficult to push and the blue piece with the flanges that should be connected to the plastic sheath broke and the brush would not advance out of the sheath.Provider decided to obtain biopsy rather than obtain specimen with cytology brush.Manufacturer response for gastrointestinal cytology brush, disposable gastrointestinal cytology brush (per site reporter).Equipment failure reported to conmed representative on 10/18/19.Product will be returned 10/28/19 via (b)(6) ground tracking number (b)(6).
 
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Brand Name
DISPOSABLE GASTROINTESTINAL CYTOLOGY BRUSH
Type of Device
ENDOSCOPIC CYTOLOGY BRUSH
Manufacturer (Section D)
CONMED CORPORATION
525 french road
utica NY 13502
MDR Report Key9353860
MDR Text Key167367841
Report Number9353860
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 10/28/2019,10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number158R
Device Catalogue Number158R
Device Lot Number201805314
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/28/2019
Event Location Hospital
Date Report to Manufacturer11/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age21535 DA
Patient Weight73
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