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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOBBS MEDICAL, INC. UNKOWN CYTOLOGY BRUSH

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HOBBS MEDICAL, INC. UNKOWN CYTOLOGY BRUSH Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pneumothorax (2012); Bronchial Hemorrhage (4456)
Event Type  Injury  
Event Description
According to the literature, prospective study evaluated the role of operators' experience as well as lesion- and procedure characteristics on diagnostic yield of electromagnetic navigation bronchoscopy (enb) procedures in the hands of novice enb operators.Patients underwent enb procedures between may 2018 and february 2020.All procedures were performed using the superdimension navigation system 7.1.215 procedures were performed with forceps used in 190 patients, needle used in 42 patients and cytobrushes used in 120 patients.Complications included: bronchial hemorrhage requiring a balloon catheter in 1 patient and pneumothorax requiring chest tube insertion in 2 patients.Publication title: diagnostics.Article title: when pulmonologists are novice to navigational bronchoscopy, what predicts diagnostic yield? date: 12 december 2022.Hobbs medical brushes are distributed as superdimension-branded accessories to the superdimension navigation system.No malfunction of any device was reported.
 
Manufacturer Narrative
Waiting confirmation from study author to confirm if hobbs medical devices were involved.
 
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Brand Name
UNKOWN CYTOLOGY BRUSH
Type of Device
CYTOLOGY BRUSH
Manufacturer (Section D)
HOBBS MEDICAL, INC.
8 spring street
stafford springs CT 06076
Manufacturer (Section G)
HOBBS MEDICAL, INC.
8 spring street
stafford springs CT 06076
Manufacturer Contact
jennifer hodge
8 spring st.
stafford springs, CT 06076
8606845875
MDR Report Key16589479
MDR Text Key311743247
Report Number1220592-2023-00002
Device Sequence Number1
Product Code FDX
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/20/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/21/2023
Initial Date FDA Received03/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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